Topic

surgical-apparel

Gowns, drapes, masks, and protective surgical apparel.

Product Guides22 min read

Surgical Drapes: 21 CFR 878.4370 Barrier, Sterility, and Accessory Specification for Buyers

A buyer specification guide to 21 CFR 878.4370 surgical drapes, PUI versus KKX/PLY 510(k) paths, ASTM F1670 Level 4 barrier testing, fenestration geometry, and accessory codes.

Sep 9, 2026 · By Ran Chen

Product Guides23 min read

Isolation and Non-Surgical Gowns: FDA Class, Critical Zones, and ASTM F3352 Versus Surgical Gowns

A technical procurement guide to 21 CFR 878.4040 isolation and non-surgical gowns: FDA product codes OEA, FYC, and QPC, PB70 barrier thresholds that trigger 510(k) clearance, full-garment critical zones, and ASTM F3352 conformity.

Sep 8, 2026 · By Ran Chen