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Medical PPE categories and certification standards

Medical PPE for healthcare settings covers: filtering facepiece respirators — N95 (NIOSH 42 CFR Part 84: ≥95% filtration of ≥0.3μm non-oil-based particles; uses and fit test required); N99 (≥99%) and N100 (≥99.97%); European equivalent: EN 149 FFP1 (≥80% filtration), FFP2 (≥94%, equivalent to N95), FFP3 (≥99%); Chinese equivalent: GB 2626 KN90/KN95/KN100; Australian: AS/NZS 1716 P1/P2/P3; key quality indicators: filtration efficiency test, breathability (pressure drop at 85L/min), strap strength, retention force of nose piece; NIOSH certification requires third-party laboratory testing and factory audit — verify current certification at NIOSH Certified Equipment List (CDC website); surgical masks (medical face masks) — as distinct from respirators: surgical masks protect patients from droplets generated by the HCW and provide fluid barrier protection; they do not achieve the sealed fit required for respiratory protection; ASTM F2100 (US: L1/L2/L3) and EN 14683 (EU: Type I/II/IIR); isolation gowns and surgical gowns — AAMI PB70 (US) defines four barrier performance levels (Level 1–4) for liquid-barrier protective apparel; Level 1–2 for basic isolation; Level 3 for moderate-to-high risk procedures; Level 4 for high-risk procedures with continuous fluid exposure; EN 13795 (EU) for surgical drapes and gowns; face shields and eye protection — ANSI Z87.1 (US) and EN 166 (EU) govern eye and face protection; medical coveralls — EN 13982-1 (EU, Type 5 solid particle protection), EN 14126 (infective agents); and medical gloves — covered under disposable supplies above.