CROSS-STANDARD public interest · PPE / respirator (mask)
China-to-Sri Lanka PPE Respirator (FFP 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 / GB 19083) documentation against Sri Lanka market requirements: Sri Lanka Standards Institution (SLSI) conformity certification and import inspection, the SLS mark, SLS standards adopting IEC/EN (EN 149 FFP1/FFP2/FFP3), the Department of Labour occupational-safety framework, and the medical-mask route via the national health regulator. Colombo is the principal port of entry.
Dataset 2026-06-11
Last verified 2026-06-15
6 rows
GAP MATRIX
Compliance Gap Matrix
| Compliance item | Common China baseline | Sri Lanka (SLSI) | Gap / action | Source + verification date |
|---|---|---|---|---|
| Conformity Assessment — SLSI Certification, SLS Mark, and Import Inspection | For industrial respiratory protection under GB 2626-2019 (KN95), China applies a compulsory certification (CCC) scheme administered by SAMR/CNCA and third-party bodies (e.g., CQC), with type testing by a CNAS-accredited laboratory plus factory inspection. For medical-protective masks (GB 19083), NMPA registration as a medical device (commonly Class II) is required. Neither the CCC scheme nor NMPA registration is automatically recognised by SLSI as satisfying Sri Lankan conformity certification or import inspection; they may be submitted as supporting evidence but SLSI conducts its own assessment.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (CCC mandatory certification under SAMR/CNCA) GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II medical device registration) |
Filtering facepiece respirators entering Sri Lanka are assessed through the Sri Lanka Standards Institution (SLSI), the national standards body that operates product certification (the SLS mark / product certification scheme) and import inspection. The practical route for an exporter is: (1) determine the applicable SLS standard — Sri Lankan standards commonly adopt IEC/EN texts, so for FFP respirators the EN 149 (FFP1/FFP2/FFP3) performance content is the working reference; (2) a Sri Lanka importer of record submits the product, the manufacturer's test reports, and product documentation to SLSI for conformity assessment; (3) SLSI evaluates the documentation and may require sample testing and/or factory information before the product is released or before an SLS certification licence is granted; (4) import inspection at the port of entry (Colombo is the principal port) verifies that the consignment matches the assessed product and documentation. Occupational use additionally sits under the Department of Labour framework. Self-declaration by the foreign manufacturer alone does not clear SLSI conformity; a local importer and SLSI assessment are required.Sri Lanka Standards Institution (SLSI) — product certification scheme (SLS mark) and import inspection SLS standards adopting IEC/EN texts — EN 149 (FFP1/FFP2/FFP3) as the working performance reference for filtering facepiece respirators Department of Labour (Sri Lanka) — occupational-safety framework for workplace respiratory protective equipment |
The conformity route must be re-run through SLSI with a local importer. Specific gaps: (1) a Sri Lanka importer of record must be engaged to lodge the SLSI conformity / import-inspection submission; (2) Chinese CCC certificates and NMPA registrations do not by themselves clear SLSI conformity — SLSI conducts its own documentary assessment and may require sample testing; (3) the product must be mapped to the applicable SLS standard (which adopts EN 149 content for FFP respirators), and test reports should demonstrate EN 149 performance rather than GB 2626 only; (4) import inspection at Colombo will check consignment-to-documentation consistency; (5) occupational-use placement must also respect the Department of Labour framework; (6) the importer must retain the technical documentation for inspection.[INFORMATIONAL] Filtering respirators imported into Sri Lanka are routed through SLSI conformity certification and import inspection, with the SLS mark and SLS standards that commonly adopt EN 149 content. A Sri Lanka importer of record and an SLSI assessment are required; Chinese CCC or NMPA certifications may support the file but do not by themselves clear SLSI conformity. Exporters should map the product to the applicable SLS/EN 149 standard and prepare for documentary review and possible sample testing before shipment to Colombo. | Sri Lanka Standards Institution (SLSI)2026-06-15 · reference |
| Product Labelling and Marking Requirements — FFP Respirators (SLS/EN 149) | GB 2626-2019 Clause 7 specifies Chinese marking for non-powered air-purifying particle respirators. On the product: manufacturer name or trademark, product name, model, standard number (GB 2626-2019), performance class (KN90 or KN95), and NR or R designation. On the packaging: manufacturer name, address and contact, production date and shelf life (or expiry), lot number, storage conditions, and instructions for use in Chinese. The CCC mark appears on the product and packaging. Key differences from Sri Lanka: Chinese markings are in Chinese and cite GB 2626; the CCC mark is used rather than the SLS mark; and there is no four-digit conformity-body number.GB 2626-2019 — Clause 7 (Marking and packaging requirements) China CCC (3C) mark — mandatory product certification mark on product and packaging |
For FFP respirators entering Sri Lanka through the SLSI/occupational route, the applicable SLS standard adopting EN 149 sets the product-marking content, to be permanently and legibly applied to each respirator and its packaging. Markings on the device typically include: the standard number/year, the manufacturer name or trademark, the type designation (model), the performance class (FFP1/FFP2/FFP3), the NR (not re-usable) or R (re-usable) designation, and the D suffix where the dolomite clogging test is passed. On the packaging: manufacturer name and address, storage conditions, lot/batch number or shelf-life/expiry, and instructions for use. Instructions should be intelligible to the Sri Lanka user — practically English, with Sinhala and/or Tamil as appropriate for the intended user. Where the product is licensed under the SLSI scheme, the SLS mark is applied per SLSI rules. There is no CE mark or notified-body number requirement; the SLS mark replaces the CE mark for the national conformity indication.Applicable SLS standard adopting EN 149 — marking content (standard number, class, NR/R, D suffix) Sri Lanka Standards Institution (SLSI) — SLS mark application rules and import inspection Sri Lanka language practice — instructions intelligible to the user (English, with Sinhala and/or Tamil as appropriate) |
Typical labelling gaps for Chinese manufacturers shipping to Sri Lanka: (1) STANDARD CITATION: the product/packaging should reference the applicable SLS standard adopting EN 149 (FFP1/FFP2/FFP3) rather than GB 2626-2019, and the performance-class marking should be the FFP class, not KN90/KN95. (2) LANGUAGE: Chinese-only instructions do not serve the Sri Lanka user; instructions should be intelligible to the intended user, practically in English with Sinhala and/or Tamil as appropriate. (3) CONFORMITY MARK: the CCC mark should not be presented as a Sri Lankan conformity mark; where licensed under the SLSI scheme, the SLS mark is applied instead. (4) NO MISLEADING KN95-AS-FFP2 LABELLING: marking a product KN95 while marketing it as FFP2 is misleading because the test methods differ; the class shown should match the standard actually certified. (5) TRACEABILITY: clear lot/batch number and shelf-life indication support import inspection and importer traceability.[INFORMATIONAL] FFP respirators for the Sri Lanka market require marking content per the applicable SLS standard adopting EN 149 (performance class, NR/R, D suffix, standard number) and user-intelligible instructions (practically English, with Sinhala and/or Tamil as appropriate). The SLS mark applies where the product is licensed under the SLSI scheme; there is no CE mark or notified-body number. Chinese-only labelling, the CCC mark, and GB 2626 references are not sufficient, and marking a product KN95 while marketing it as FFP2 is misleading. | Sri Lanka Standards Institution (SLSI)2026-06-15 · reference |
| SLS Mark, Conformity Documentation, and Importer of Record | China does not use the SLS mark. Domestic conformity is shown via the CCC mark (mandatory for GB 2626 respirators) or NMPA registration (for GB 19083 / YY 0469 medical masks). The CCC mark is affixed after certification by a CNCA-authorised body. There is no exact equivalent of a Sri Lanka importer-of-record obligation for the domestic Chinese market, because the domestic manufacturer is the responsible party. CCC marks and NMPA registration documents are not accepted by SLSI as a substitute for SLSI conformity or the SLS mark, though they may be submitted as supporting evidence.China CCC (3C) certification — CNCA mandatory certification system for GB 2626-2019 industrial respirators NMPA medical device registration — for GB 19083 / YY 0469 medical masks under drug/device law |
Before FFP respirators are released onto the Sri Lanka market, the local importer of record (acting for the foreign manufacturer) must: (1) where the product is brought under the SLSI product certification scheme, obtain the SLS mark licence and apply the SLS mark to the product and packaging in accordance with SLSI scheme rules; (2) maintain conformity documentation — the manufacturer's technical file, test reports demonstrating performance to the applicable SLS standard (adopting EN 149), and any certificate issued by SLSI or a competent body; (3) be established in Sri Lanka as the importer of record responsible for SLSI conformity, import-inspection correspondence, and contact with enforcement bodies. SLSI import inspection at the port of entry (Colombo) checks that the consignment matches the assessed product and its documentation. Unlike a CE/Notified-Body regime, there is no four-digit notified body number to affix; the operative national conformity mark is the SLS mark where the product is licensed under the SLSI scheme.Sri Lanka Standards Institution (SLSI) — product certification scheme and SLS mark licensing rules SLSI import inspection at the port of entry (Colombo) Applicable SLS standard adopting EN 149 — performance basis cited in the conformity documentation |
Distinct gaps must be closed for Sri Lanka: (1) IMPORTER OF RECORD: a Sri Lanka-established importer must be appointed to hold SLSI conformity responsibility and lodge the import-inspection submission — Chinese manufacturers commonly lack this and must engage a local importer/agent before first shipment. (2) SLS MARK: where the product is brought under the SLSI certification scheme, the SLS mark licence must be obtained and the SLS mark correctly applied; the CCC mark does not satisfy this and should not be presented as a Sri Lankan conformity mark. (3) CONFORMITY DOCUMENTATION: a technical file with EN 149-based test reports (not GB 2626 only) and any SLSI/competent-body certificate must be retained and made available at import inspection. (4) CONSIGNMENT MATCH: the shipment marking and documentation must match the assessed product so the Colombo import inspection clears without hold-up.[INFORMATIONAL] For the Sri Lanka market, the operative conformity elements are a local importer of record, SLSI conformity documentation (technical file plus EN 149-based test reports), and the SLS mark where the product is licensed under the SLSI scheme. There is no notified-body number to affix. Chinese CCC marks and NMPA registrations do not substitute for these and should be presented only as supporting evidence. Documentation and consignment marking must match the assessed product for import inspection at Colombo to clear. | Sri Lanka Standards Institution (SLSI)2026-06-15 · reference |
| Filtering Facepiece Respirator Safety — SLS/EN 149 FFP Performance Requirements | China's primary standard for non-powered air-purifying particle respirators is GB 2626-2019, with classes KN90 and KN95. GB 2626-2019 is a mandatory national standard enforced by SAMR; KN95 requires at least 95 percent filtration efficiency against NaCl particles at 85 L/min. Key differences from EN 149: GB 2626 uses sodium chloride (NaCl) aerosol only (EN 149 uses both NaCl and paraffin oil), does not require the practical (simulated workplace) performance test, and lacks the dolomite clogging resistance test. A Chinese CNAS-accredited lab report to GB 2626 demonstrates KN95 performance but is not numerically equivalent to EN 149 FFP2, so SLSI assessment against the SLS/EN 149 standard cannot simply accept a GB 2626 report without mapping.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) |
Filtering facepiece respirators placed on the Sri Lanka market through the SLSI/occupational route are assessed against the applicable SLS standard, which commonly adopts EN 149 (Filtering half masks to protect against particles). EN 149 specifies three performance classes: FFP1 (filter penetration limit, lower protection), FFP2 (at least 94 percent filtration, total inward leakage at most 8 percent) and FFP3 (at least 99 percent filtration, total inward leakage at most 2 percent). The requirements cover filtration efficiency against liquid and solid aerosols, inhalation and exhalation breathing resistance, carbon dioxide content of inhaled air, practical performance (simulated workplace), dolomite clogging resistance, and flammability. Respirators may be marked NR (not re-usable) or R (re-usable) and may carry the D suffix if the dolomite clogging test is passed. The Department of Labour occupational-safety framework governs workplace selection and use. Note that Sri Lanka's grid is 230 V, 50 Hz (the 50 Hz frequency matches China; the voltage differs from China's 220/380 V) — this is relevant only to any powered respirator accessories, not to passive FFP masks.Applicable SLS standard adopting EN 149 — Respiratory protective devices — Filtering half masks to protect against particles (FFP1/FFP2/FFP3) Sri Lanka Standards Institution (SLSI) — product certification scheme / SLS mark Department of Labour (Sri Lanka) — occupational-safety framework for selection and use of respiratory protective equipment |
Exporters should hold test evidence to the SLS/EN 149 content rather than GB 2626 only. GB 2626-2019 (KN95) reports do not by themselves demonstrate EN 149 conformity because: (1) EN 149 requires paraffin oil aerosol testing in addition to NaCl; (2) EN 149 requires a simulated workplace performance test (total inward leakage on human subjects); (3) EN 149 requires the dolomite clogging test for valve masks; (4) filtration thresholds differ numerically (KN95 = 95 percent NaCl only; FFP2 = 94 percent both aerosols plus a total inward leakage limit). SLSI may accept EN 149 test reports from a competent laboratory and/or require sample testing; a plain GB 2626 report typically needs supplementing with EN 149 evidence before SLS certification or import clearance.[INFORMATIONAL] FFP respirators entering Sri Lanka through the SLSI/occupational route are assessed against the applicable SLS standard adopting EN 149 (FFP1/FFP2/FFP3). Chinese GB 2626-2019 (KN95) certification demonstrates KN95 performance but is not numerically equivalent to EN 149 FFP2; SLSI may require EN 149 test reports and/or sample testing. Exporters should prepare EN 149 evidence (including the paraffin oil aerosol test and simulated workplace test absent from GB 2626) rather than relying on a GB 2626 report alone. | Sri Lanka Standards Institution (SLSI)2026-06-15 · reference |
| Medical-Protective / Surgical Mask Safety — Health-Regulator Route (Not the SLSI Occupational PPE Route) | GB 19083-2010 (Technical requirements for medical protective mask) requires at least 95 percent filtration efficiency (NaCl aerosol), bacterial filtration efficiency, surface moisture resistance, and pressure-differential testing, and is enforced by NMPA as a Class II medical device in China. YY 0469-2011 (medical surgical mask) is likewise an NMPA Class II medical device focused on bacterial filtration efficiency and fluid resistance for surgical use. Products certified under GB 19083 or YY 0469 are regulated domestically as medical devices, not as GB 2626 industrial PPE. The Sri Lanka equivalent for these is the national health regulator's medical pathway, with EN 14683-type performance as the reference — not the SLSI/EN 149 occupational route.GB 19083-2010 — Technical requirements for medical protective mask (NMPA, medical device classification) YY 0469-2011 — Medical surgical mask — Technical requirements (NMPA Class II medical device) |
This row addresses medical-protective and surgical masks for completeness, because Chinese manufacturers frequently hold GB 19083 (medical-protective) or YY 0469 (surgical) certification. In Sri Lanka, masks intended to protect the patient or environment (surgical, infection control) are routed through the national health regulator's medical-device / medical-supply pathway rather than the SLSI occupational PPE route, with EN 14683-type medical-face-mask performance content as the working reference rather than EN 149. A product that genuinely serves only a particle-filtration (wearer-protection) purpose stays on the SLSI/EN 149 route covered in the safety-001 row; a product that adds medical claims is pulled toward the health-regulator pathway. A product claiming both wearer protection and patient/environment protection may need to satisfy both routes.National health regulator (Sri Lanka) — medical-device / medical-supply registration pathway for surgical and medical-protective masks EN 14683-type medical face mask performance content as the working reference (vs EN 149 for PPE respirators) GB 19083-2010 / YY 0469-2011 (China) — medical-mask standards that map to the health-regulator route, not the SLSI occupational PPE route |
GB 19083 / YY 0469 certification is for China's domestic medical-device market and has no automatic recognition in Sri Lanka. Exporting a medically claimed mask to Sri Lanka requires the national health-regulator pathway (medical-device / medical-supply registration via the local importer), with EN 14683-type evidence rather than the SLSI/EN 149 occupational route. If the same product also makes wearer-protection (particle) claims, it may additionally require the SLSI/EN 149 conformity covered in safety-001 — a dual route that is materially more burdensome. The exporter must decide the intended-purpose claim first, because that determines which Sri Lanka authority and which performance standard apply.[INFORMATIONAL] Chinese GB 19083 / YY 0469 medical-mask certification is not automatically recognised in Sri Lanka. Medically claimed masks follow the national health regulator's medical pathway (EN 14683-type reference) via a local importer, not the SLSI/EN 149 occupational PPE route. A particle-filtration-only product stays on the SLSI/EN 149 route; a product claiming both wearer and patient/environment protection may need both. The intended-purpose claim should be decided before submission, since it determines which Sri Lanka authority and standard apply. | Sri Lanka Standards Institution (SLSI)2026-06-15 · reference |
| CRITICAL BOUNDARY: PPE Respirator vs. Medical Mask — Which Sri Lanka Route Applies? | China uses a three-track classification system: (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 (filtration efficiency at least 95 percent, medical-grade) — for highly infectious environments, administered by NMPA as a Class II medical device; (3) SURGICAL MASK: YY 0469-2011 (medical surgical mask, technical requirements) — for surgical use, NMPA Class II medical device. This three-track system maps only partially to Sri Lanka's split between the SLSI/occupational route and the health-regulator route; notably KN95 (GB 2626) is not numerically identical to FFP2 (EN 149) because the test methods differ, and Chinese YY 0469 / GB 19083 medical masks map to the Sri Lanka health-regulator route rather than the SLSI occupational PPE route.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 classification of the product determines which Sri Lanka pathway applies, and the determining factor is the INTENDED PURPOSE declared by the manufacturer. (A) FFP / FILTERING RESPIRATORS (PPE / occupational route): products intended to protect the WEARER against airborne particles and aerosols (industrial, occupational, emergency use). Route: SLSI conformity certification against the applicable SLS standard, which commonly adopts EN 149 (FFP1/FFP2/FFP3) performance content; workplace use additionally sits under the Department of Labour occupational-safety framework. (B) SURGICAL / MEDICAL MASKS (health-regulator route): products intended to protect the PATIENT or ENVIRONMENT from the wearer's emissions (infection control, surgical use). Route: the national health regulator (medical-device / medical-supply pathway), with SLS / EN 14683-type performance content as the reference rather than EN 149. (C) DUAL-PURPOSE PRODUCTS: a product claiming BOTH wearer protection and patient/environment protection may need to satisfy BOTH the SLSI/occupational route AND the health-regulator route, which is materially more burdensome. As with other markets, adding surgical or medical claims to an FFP respirator changes the regulatory route and can trigger the health-regulator pathway in addition to SLSI conformity.SLSI conformity certification + Department of Labour occupational-safety framework (respirators protecting the wearer: SLS/EN 149 FFP route) National health regulator — medical-device / medical-supply pathway (surgical masks protecting patients/environment: SLS/EN 14683-type route) EN 149 (FFP1/FFP2/FFP3) — filtering half masks performance reference, as adopted into SLS standards EN 14683-type — medical face masks performance reference for the medical route |
The single most important classification decision is what the product label and instructions claim. (1) If the product claims WEARER PROTECTION against particles/aerosols (worker safety, industrial, emergency): the SLSI conformity route applies (SLS standard adopting EN 149), plus Department of Labour occupational placement. (2) If the product claims PATIENT/ENVIRONMENT PROTECTION (surgical, infection control): the national health-regulator pathway applies (medical-mask route, EN 14683-type reference). (3) If the product claims BOTH: both routes may apply. COMMON EXPORT MISTAKE: Chinese manufacturers label KN95 (GB 2626) masks with surgical or medical wording to target multiple markets; in Sri Lanka, medical claims pull the product toward the health-regulator pathway, while occupational/particle claims keep it on the SLSI/Department of Labour route. Mixed or inconsistent claims risk import-inspection hold-ups and the wrong assessment route.[INFORMATIONAL — CRITICAL BOUNDARY] In Sri Lanka, an FFP filtering respirator that protects the wearer follows the SLSI conformity route (SLS standard adopting EN 149) plus the Department of Labour occupational framework, whereas a surgical/medical mask that protects the patient or environment follows the national health regulator's medical-mask pathway (EN 14683-type reference). The two routes must not be mixed; products claiming both may need both. Chinese KN95 (GB 2626) respirators should be presented on the SLSI/occupational route — adding surgical or medical claims pulls the product into the health-regulator pathway and changes the documentation required. | Sri Lanka Standards Institution (SLSI)2026-06-15 · reference |
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- Sri Lanka Standards Institution (SLSI) · accessed 2026-06-15 · reference · used in 6 rows