CROSS-STANDARD public interest · PPE / respirator (mask)

China-to-South Korea PPE Respirator (Anti-Dust Mask) Compliance Gap Matrix

AI-compiled from official public sources — cross-checked by multiple AI models, not human-verified. Informational only; see disclaimer. Public-interest, source-linked comparison of Chinese PPE respirator (KN95 / GB 2626) documentation against South Korean requirements under the Industrial Safety and Health Act (산업안전보건법), KOSHA/KMOEL anti-dust mask (방진마스크) Type Approval, standard KS M 6673 (special / class 1 / class 2 — 특급/1급/2급), mandatory KCs safety-certified protective equipment marking, and the critical anti-dust-mask-vs-medical (KF) mask boundary regulated separately by MFDS.

Dataset 2026-06-11 Last verified 2026-06-15 6 rows

Compliance Gap Matrix

Gap matrix
Compliance item Common China baseline South Korea (KC / KATS) Gap / action Source + verification date
Conformity Assessment — Anti-Dust Mask Type Approval (KOSHA/KMOEL Safety Certification 안전인증) For industrial respiratory protection under GB 2626-2019 (KN95), China applies a compulsory certification (CCC) scheme administered by CNCA and third-party certification bodies (e.g., China Quality Certification Centre, CQC). The conformity assessment involves type testing by a CNAS-accredited laboratory followed by factory inspection. For medical-protective masks (GB 19083), NMPA registration is required as a medical device (Class II in most cases). Neither the CCC scheme nor the NMPA medical device registration is recognised as equivalent to KOSHA/KMOEL anti-dust mask Safety Certification (안전인증) under the Korean Industrial Safety and Health Act.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (CCC mandatory certification under CNCA)
GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II medical device registration)
Anti-dust masks (방진마스크) used as occupational respiratory protective equipment are designated 의무안전인증대상 보호구 (mandatory safety-certification-target protective equipment) under the Industrial Safety and Health Act (산업안전보건법) Article 84 and its Enforcement Decree. Conformity assessment is administered by KMOEL (Ministry of Employment and Labor) and operated by KOSHA (Korea Occupational Safety and Health Agency) as the designated certification body. The procedure requires: (1) Product (design/type) examination — the manufacturer submits technical documentation and specimens; KOSHA evaluates the design and performs type testing to KS M 6673; (2) Factory/quality management system inspection — KOSHA audits the manufacturing site and quality control system; (3) Issuance of a Safety Certification (안전인증서) and the right to apply the KCs safety-certification mark; (4) Periodic confirmation (정기 확인) — KOSHA conducts follow-up audits and product checks at intervals (typically every two to three years) to verify continued conformity. The manufacturer cannot self-certify anti-dust masks in the mandatory category — KOSHA/KMOEL involvement is required throughout.Industrial Safety and Health Act (산업안전보건법), Article 84 (Safety certification) and Enforcement Decree — anti-dust mask as mandatory safety-certification-target protective equipment
KOSHA / KMOEL Safety Certification (안전인증) procedure — Notice on Safety Certification of Protective Equipment (보호구 안전인증 고시)
KS M 6673 — Anti-dust masks (방진마스크) test and classification standard
The entire conformity assessment must be re-run with KOSHA/KMOEL. Specific gaps: (1) KOSHA, as the KMOEL-designated certification body, must perform the anti-dust mask Safety Certification (안전인증) including type testing to KS M 6673; (2) Chinese CCC certificates and NMPA registrations do not substitute for the KOSHA type approval; (3) A Safety Certification certificate (안전인증서) must be obtained BEFORE the KCs mark can be applied; (4) Ongoing production must remain covered by the periodic confirmation (정기 확인) audits conducted by KOSHA; (5) The Safety Certification must be renewed or amended if the product design or materials change; (6) A Korean importer or a designated domestic representative must hold the technical file (including KS M 6673 test reports, design drawings, and Korean-language user instructions) and respond to KOSHA market surveillance.[INFORMATIONAL] Occupational anti-dust masks (방진마스크) require mandatory KOSHA/KMOEL Safety Certification (안전인증) for both type examination (to KS M 6673) and ongoing production confirmation (정기 확인). Chinese CCC or NMPA certifications do not satisfy this requirement. Exporters must engage KOSHA as the KMOEL-designated certification body before placing any anti-dust mask on the South Korean occupational market. Korea Law Information Center (law.go.kr) / Korea Occupational Safety and Health Agency (KOSHA)2026-06-15 · reference
Product Labelling and Marking Requirements — Anti-Dust Masks (KS M 6673 + KOSHA 안전인증) GB 2626-2019 Clause 7 specifies Chinese marking requirements for non-powered air-purifying particle respirators. Required on the product: manufacturer name or trademark, product name, product model, standard number (GB 2626-2019), performance class (KN90 or KN95), 'NR' or 'R' designation. Required on the packaging: manufacturer name, address, and contact, production date and shelf life (or expiry date), lot number, storage conditions, instructions for use in Chinese. The CCC mark must appear on the product and packaging. Key differences from South Korea: Chinese markings are in Chinese only (Korea requires Korean-language instructions and the KS reference); the CCC mark replaces the KCs mark; KN90/KN95 class designations differ from 특급/1급/2급; and no KOSHA safety certification number is shown.GB 2626-2019 — Clause 7 (Marking and packaging requirements)
China CCC (3C) mark — mandatory product certification mark on product and packaging
KS M 6673 and the Notice on Safety Certification of Protective Equipment (보호구 안전인증 고시) specify mandatory marking to be permanently and legibly applied to each anti-dust mask and its packaging. Required markings ON THE DEVICE include: (1) Name or trademark of the manufacturer; (2) Type/model designation; (3) Performance class (특급 / 1급 / 2급); (4) Filtering-facepiece (안면부여과식) or replaceable-cartridge (분리식) type indication; (5) Disposable or reusable designation; (6) the KCs safety-certification mark followed by the KOSHA safety certification number. Required on the PACKAGING: manufacturer name and address, the standard reference (KS M 6673), production/lot information, storage conditions, shelf life or expiry (where applicable), and instructions for use in Korean. Instructions for use must include: donning/doffing procedure, fit-check (밀착성) instructions, limitations of use, storage conditions, and care/maintenance for reusable types. The KCs mark and certification number must comply with the format prescribed in the KOSHA safety-certification notice.KS M 6673 — marking requirements for anti-dust masks (방진마스크)
Industrial Safety and Health Act (산업안전보건법) — Notice on Safety Certification of Protective Equipment (보호구 안전인증 고시), KCs marking and information requirements
Korean Labeling rules for the KCs/KC mark format (KOSHA safety-certification notice)
Multiple labelling gaps are typical for Chinese manufacturers: (1) LANGUAGE: Chinese-only instructions do not satisfy Korean requirements — full translation into Korean is mandatory for instructions for use, warnings, and class indication. (2) KCs FORMAT: The KCs mark must comply with the format in the KOSHA safety-certification notice and must be accompanied by the KOSHA certification number. The CCC mark must be removed or covered for Korean occupational-market products. (3) CERTIFICATION NUMBER: The KOSHA safety certification number must appear with the KCs mark on the product. (4) STANDARD CITATION: The product must reference KS M 6673 and the Korean class (특급/1급/2급), not GB 2626-2019 / KN95. (5) SHELF LIFE: Korean market practice requires clear lot number and shelf-life/expiry indication for traceability. (6) NO 'KN95' CLAIM: Labelling a Korean-market mask as 'KN95' instead of its KS M 6673 class (e.g., 1급) is misleading — the two systems use different test methods and thresholds. KOSHA market surveillance can flag masks marketed with mismatched class claims, and using the 'KF' designation (an MFDS quasi-drug grade) on a KOSHA-route occupational mask is non-compliant.[INFORMATIONAL] Anti-dust masks for the South Korean occupational market require product labelling that complies with KS M 6673 (performance class 특급/1급/2급, facepiece/cartridge type, disposable/reusable, standard number) and the KOSHA safety-certification notice (KCs mark with KOSHA certification number). Instructions for use must be in Korean. Chinese-language-only labelling, CCC marks, and GB 2626 / KN95 references are not sufficient. Labelling a Korean-market mask as 'KN95' instead of its KS M 6673 class, or using the MFDS 'KF' designation on a KOSHA-route occupational mask, can be flagged by Korean market surveillance as misleading or misclassified. Korea Occupational Safety and Health Agency (KOSHA) / KATS e-나라표준인증 (standard.go.kr)2026-06-15 · reference
KCs Safety-Certification Mark, Safety Certification Certificate, and Korean Importer/Representative China does not require the KCs mark. Domestic market conformity is demonstrated via the CCC mark (mandatory for GB 2626 respirators) or NMPA registration (for GB 19083 medical masks). The CCC mark (China Compulsory Certification) is affixed after certification by a CNCA-authorised body. There is no equivalent to a Korean importer/representative requirement for the domestic Chinese market — Chinese law does not mandate a domestic legal representative for the domestic market conformity pathway. The CCC mark and NMPA registration documents are not accepted by Korean (KOSHA/KMOEL) market surveillance authorities as evidence of KCs conformity.China CCC (3C) certification — CNCA mandatory certification system for GB 2626-2019 industrial respirators
NMPA medical device registration — for GB 19083 medical-protective masks under drug/device law
Before placing anti-dust masks on the South Korean occupational market, the manufacturer (or Korean importer/representative) must: (1) Affix the KCs safety-certification mark (안전인증 표시 / KCs 마크) to the product and its packaging — the KCs mark is the protective-equipment variant of the KC mark and must be accompanied by the safety certification number issued by KOSHA; (2) Hold the Safety Certification certificate (안전인증서) issued by KOSHA, which lists the product, model, applicable standard (KS M 6673), class (특급/1급/2급), the certification body (KOSHA), and the certificate number; (3) Ensure a Korean importer or domestic representative is responsible for keeping the technical file, retaining records, and responding to KMOEL/KOSHA market surveillance. The KCs mark and the KOSHA safety certification number must appear on the product. For products entering through the general consumer-product framework, the KC mark is administered under KATS (KATS, under MOTIE), but occupational respiratory protective equipment specifically uses the KCs (KOSHA, under KMOEL) safety-certification route.Industrial Safety and Health Act (산업안전보건법), Article 84 (Safety certification) and Notice on Safety Certification of Protective Equipment (보호구 안전인증 고시) — KCs mark and safety certification number
KC mark framework under KATS (Korean Agency for Technology and Standards, MOTIE) — general KC mark, with KCs as the KOSHA-administered protective-equipment variant
Three distinct gaps must be closed: (1) KCs MARK: The KCs mark with the KOSHA safety certification number must be physically on the product and packaging. Existing CCC or Chinese quality marks do not satisfy this, and the CCC mark must be removed or covered for the Korean occupational market. (2) SAFETY CERTIFICATION CERTIFICATE: A KOSHA-issued 안전인증서 must be obtained, listing the applicable standard (KS M 6673), class (특급/1급/2급), certification body, and certificate number. (3) KOREAN IMPORTER/REPRESENTATIVE: A Korean importer or designated domestic entity must be responsible for the technical file and for responding to KMOEL/KOSHA market surveillance. Chinese manufacturers commonly lack this — appointing a Korean importer or representative and completing KOSHA certification is required before first shipment.[INFORMATIONAL] All three elements — the KCs mark (with KOSHA certification number), the Safety Certification certificate (안전인증서 to KS M 6673), and a responsible Korean importer/representative — are mandatory before any occupational anti-dust mask is placed on the South Korean market. These are distinct from the technical testing requirements and must be completed even after the KOSHA certificate is obtained. Chinese CCC marks, NMPA marks, and Chinese quality certificates do not substitute for any of these requirements. Korea Occupational Safety and Health Agency (KOSHA) / Korean Agency for Technology and Standards (KATS)2026-06-15 · reference
Anti-Dust Mask Safety — KS M 6673 Performance Requirements (특급/1급/2급) China's primary standard for non-powered air-purifying particle respirators is GB 2626-2019 (Respiratory protective equipment — Non-powered air-purifying particle respirator), with two performance classes: KN90 and KN95. GB 2626-2019 is a mandatory national standard (GB, not GB/T) enforced by SAMR. KN95 requires ≥95% filtration efficiency against NaCl particles at 85 L/min flow rate. Key differences from KS M 6673: GB 2626 KN-series uses sodium chloride (NaCl) aerosol only (KS M 6673 also uses paraffin oil for higher classes, similar to the KP/oil-based series), and the Korean class thresholds (특급 ≥99%, 1급 ≥94%, 2급 ≥80%) do not numerically coincide with KN90/KN95. Testing by a Chinese CNAS-accredited lab to GB 2626 is not recognised under the KOSHA安전인증 conformity assessment pathway.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (mandatory national standard, SAMR)
GB/T 32610-2016 — Technical specification of daily protective mask (voluntary, for general public use — not industrial PPE)
Anti-dust masks (방진마스크) placed on the South Korean market as occupational respiratory protective equipment must meet the performance requirements of the standard KS M 6673 and the Notice on Safety Certification of Protective Equipment (보호구 안전인증 고시) issued under the Industrial Safety and Health Act. KS M 6673 specifies three performance classes by filtration efficiency: 특급 (special, ≥99% / ≥99.95% depending on aerosol), 1급 (class 1, ≥94%), and 2급 (class 2, ≥80%). Requirements cover filtration (separating) efficiency against sodium chloride (NaCl) and, for the higher classes, paraffin oil (DOP/oil-based) aerosols; inhalation and exhalation resistance (breathing resistance limits); leakage / total inward leakage; dead space (carbon dioxide content of inhaled air); strength of head harness and connections; and, where an exhalation valve is fitted, valve airtightness. Masks are categorised as 안면부여과식 (filtering facepiece) or 분리식 (replaceable-cartridge), and as disposable or reusable. KOSHA type approval to KS M 6673 is mandatory before the KCs mark may be applied.KS M 6673 — Anti-dust masks (방진마스크) — Requirements, testing, classification (특급/1급/2급) — applied via KOSHA Safety Certification
Industrial Safety and Health Act (산업안전보건법) — Notice on Safety Certification of Protective Equipment (보호구 안전인증 고시)
Exporters must obtain KS M 6673 testing through the KOSHA Safety Certification (안전인증) pathway. GB 2626-2019 (KN95) test reports do NOT satisfy KS M 6673 requirements because: (1) KS M 6673 grades to 특급/1급/2급 with thresholds (≥99% / ≥94% / ≥80%) that differ numerically from KN90/KN95; (2) higher KS M 6673 classes require paraffin-oil aerosol testing in addition to NaCl; (3) the test is performed and accepted only via KOSHA as the KMOEL-designated certification body, including factory/QMS audit. A complete re-test to KS M 6673 under KOSHA安전인증 is required — partial bridging from GB 2626 (KN95) is not accepted, and a KN95 product is not automatically treated as a 1급 anti-dust mask.[INFORMATIONAL] Occupational anti-dust masks (방진마스크) are mandatory safety-certification-target PPE under the Industrial Safety and Health Act. The KCs mark is mandatory and requires KOSHA/KMOEL Safety Certification (안전인증) — type testing to KS M 6673 plus factory/QMS audit and periodic confirmation. KS M 6673 classes 특급/1급/2급 are the applicable grades. Chinese GB 2626-2019 (KN95) certification does not satisfy Korean requirements — full re-testing via KOSHA is required, including the paraffin-oil aerosol test for higher classes and the KOSHA-administered factory audit absent from the CCC route. Korea Occupational Safety and Health Agency (KOSHA) / KATS e-나라표준인증 (standard.go.kr)2026-06-15 · reference
Health/Medical KF Mask Safety — MFDS Quasi-Drug (Korea Only — Not the Occupational PPE Route) GB 19083-2010 (Technical requirements for medical protective mask) requires ≥95% filtration efficiency (NaCl aerosol), bacterial filtration efficiency, surface moisture resistance, and pressure differential testing. It is enforced by NMPA (National Medical Products Administration) as a medical device in China. Products certified under GB 19083 in China are regulated as medical devices domestically, not as industrial PPE under GB 2626. The Korean equivalent for a public health mask would be the MFDS quasi-drug (보건용 마스크, KF) route; a product also claiming an occupational protective function would additionally require KOSHA Safety Certification to KS M 6673 — a dual-certification pathway.GB 19083-2010 — Technical requirements for medical protective mask (NMPA, medical device classification) This row addresses the Korean health/medical mask route (보건용 마스크, KF grades) for completeness. In South Korea, masks intended for general public health protection against fine dust, yellow dust, or droplets are classified as quasi-drugs (의약외품) under the Pharmaceutical Affairs Act and are regulated by MFDS — NOT by KOSHA. They carry KF80/KF94/KF99 grading per the MFDS 의약외품 기준 및 시험방법 (Korea standards and test methods for quasi-drugs), and require MFDS item permission or notification. A product that serves both an occupational PPE function (industrial dust filtration) and a 보건용 health function would fall under a dual-regulation overlap: the Industrial Safety and Health Act (KS M 6673, KOSHA) AND the Pharmaceutical Affairs Act (MFDS quasi-drug). The anti-dust-mask route covered in this comparison is the occupational-PPE-only route under KS M 6673. See the scope fragment (ppekr-scope) for the critical anti-dust-mask-vs-medical KF boundary.MFDS 의약외품 기준 및 시험방법 — health/medical mask (보건용 마스크) KF80/KF94/KF99 grades (Korea, mandatory, MFDS)
Industrial Safety and Health Act (KS M 6673, KOSHA) and Pharmaceutical Affairs Act (MFDS quasi-drug) — dual overlap for masks claiming both occupational and health functions
GB 19083 certification is for China's domestic medical device market and has no direct Korean equivalent recognition. Exporting a GB 19083-certified respirator to South Korea as an occupational PPE still requires full KS M 6673 type approval by KOSHA (안전인증). If the product instead targets the general public as a health mask, it must obtain MFDS quasi-drug (의약외품, KF80/KF94/KF99) item permission/notification. If the product claims both functions, it requires both KOSHA安전인증 and MFDS quasi-drug conformity. The dual-regulation pathway is significantly more burdensome than the occupational-PPE-only (KS M 6673 + KOSHA) path.[INFORMATIONAL] GB 19083 (Chinese medical-protective mask) certification is not recognised under either the Korean occupational PPE (KS M 6673 / KOSHA) or the MFDS quasi-drug (보건용/KF) pathway. Exporters must choose the correct Korean route: occupational-only (KS M 6673 + KOSHA 안전인증), MFDS quasi-drug (KF) for public health masks, or dual conformity if both claims are made. See the scope fragment for the 방진마스크 / 보건용 KF boundary which determines which regime applies. Ministry of Food and Drug Safety (MFDS) / Korea Occupational Safety and Health Agency (KOSHA)2026-06-15 · reference
CRITICAL BOUNDARY: Anti-Dust Mask (PPE) vs. Medical KF Mask (Quasi-Drug) — Which Korean Regime Applies? China uses a three-track classification system for respiratory masks: (1) INDUSTRIAL / NON-MEDICAL: GB 2626-2019 (KN90/KN95) — particle respirators for occupational use, mandatory CCC, administered by SAMR; (2) MEDICAL-PROTECTIVE: GB 19083-2010 (≥95% filtration, medical-grade) — for use in highly infectious environments (e.g., SARS, COVID wards), administered by NMPA as Class II medical device; (3) SURGICAL MASK: YY 0469-2011 (Medical surgical mask — Technical requirements) — for surgical use, bacterial filtration efficiency ≥95%, NMPA Class II medical device. The Chinese three-track system partially maps to the Korean split between occupational PPE (방진마스크 / KS M 6673) and health/medical quasi-drug (보건용/KF), but the mapping is not 1:1. Notably: KN95 (GB 2626) is not automatically accepted as KS M 6673 1급 because test methods differ; and China's GB 19083 / YY 0469 medical masks map to the Korean MFDS quasi-drug or medical-device route, not to KOSHA occupational PPE.GB 2626-2019 — Non-powered air-purifying particle respirator (KN90/KN95) — SAMR/CCC
GB 19083-2010 — Technical requirements for medical protective mask — NMPA Class II
YY 0469-2011 — Medical surgical mask — Technical requirements — NMPA Class II
GB/T 32610-2016 — Technical specification of daily protective mask (voluntary, general public — not industrial or medical)
The anti-dust-mask-versus-medical-mask boundary is one of the most commercially significant classification decisions for respiratory protection products entering the South Korean market. The determining factor is the INTENDED PURPOSE declared by the manufacturer: (A) ANTI-DUST MASK (방진마스크 — OCCUPATIONAL PPE ROUTE): Products intended to protect the WORKER against airborne particles and dust in industrial workplaces (occupational safety, mining, construction). Route: Industrial Safety and Health Act, KOSHA/KMOEL Safety Certification (안전인증), standard KS M 6673, classes 특급/1급/2급 (special / class 1 / class 2). KOSHA type approval required. (B) HEALTH / MEDICAL KF MASK (보건용 마스크 — QUASI-DRUG ROUTE): Products intended to protect the PUBLIC/WEARER against airborne particulates, yellow dust, or droplets for general health purposes. Route: Pharmaceutical Affairs Act, classified as 의약외품 (quasi-drug), regulated by MFDS (Ministry of Food and Drug Safety); KF80/KF94/KF99 grades per the MFDS 의약외품 기준 및 시험방법 (Korea standards and test methods for quasi-drugs). MFDS item permission/notification required. (C) DUAL-PURPOSE PRODUCTS: A product claiming BOTH occupational worker protection (PPE) AND a 보건용/health-mask function must satisfy BOTH the KOSHA安全인증 (KS M 6673) AND the MFDS quasi-drug pathway. This dual-regulation path is significantly more burdensome and is not interchangeable.Industrial Safety and Health Act (산업안전보건법) — anti-dust mask protecting the worker: KOSHA 안전인증 / KS M 6673 route
Pharmaceutical Affairs Act (약사법) — health/medical KF masks as quasi-drugs (의약외품): MFDS route
KS M 6673 — Anti-dust masks (방진마스크), classes 특급/1급/2급 (occupational PPE standard)
MFDS 의약외품 기준 및 시험방법 — KF80/KF94/KF99 health-mask (보건용 마스크) standard
The single most important classification decision is: what does the product label and instructions claim? (1) If the product claims WORKER PROTECTION against industrial dust/particles (occupational safety, construction, mining): → Industrial Safety and Health Act applies → KS M 6673 type approval by KOSHA (안전인증) required, with KCs marking. (2) If the product claims general HEALTH PROTECTION against fine dust, yellow dust, or droplets (보건용): → Pharmaceutical Affairs Act applies → MFDS quasi-drug (의약외품) item permission/notification required, with KF80/KF94/KF99 grading. (3) If the product claims BOTH: → Both regimes apply. COMMON EXPORT MISTAKE: Chinese manufacturers label KN95 (GB 2626) masks with both 'industrial' and 'health/medical' language to target multiple Korean channels. In South Korea, the KCs (KOSHA occupational PPE) mark and the MFDS quasi-drug 'KF' designation are governed by different ministries and laws; using one mark while claiming the function of the other is non-compliant. KOSHA and MFDS market surveillance regularly detect and recall masks marketed in the wrong category.[INFORMATIONAL — CRITICAL BOUNDARY] Health/medical KF masks (보건용 마스크, KF80/KF94/KF99) are QUASI-DRUGS (의약외품) regulated by MFDS under the Pharmaceutical Affairs Act, NOT occupational PPE. Anti-dust masks (방진마스크, KS M 6673) are occupational PPE certified by KOSHA under the Industrial Safety and Health Act — a completely different regulatory route. The two routes must not be mixed. Products claiming both functions require dual conformity. Chinese KN95 (GB 2626) respirators exported to South Korea as occupational PPE must follow the KOSHA安전인증 / KS M 6673 route — adding 'health' or 'KF' labelling triggers MFDS quasi-drug requirements that are frequently absent, causing market surveillance withdrawals. Ministry of Food and Drug Safety (MFDS) / Korea Occupational Safety and Health Agency (KOSHA)2026-06-15 · reference

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