CROSS-STANDARD · TOPIC PILLAR

China export standards for PPE / respirator (mask)

Personal protective equipment—including filtering facepiece respirators (FFP2, N95, KN95), surgical masks, and industrial PPE—is categorised as life-safety equipment, triggering some of the most demanding conformity-assessment routes in regulated trade. Exporting PPE and respirators from China requires navigating market-specific classification systems (Category III PPE under EU PPE Regulation 2016/425; NIOSH approval in the United States), mandatory third-party type-examination by notified or approved bodies, and controls on authorised representative obligations. Performance standards for filtration efficiency, breathing resistance, face-seal leakage, and durability must be demonstrated under prescribed test conditions. The pages below compare the applicable standards, approval authorities, and post-market surveillance requirements for each market covered.