FDA-recognized standard · General Plastic Surgery/General Hospital
ASTM F1671: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
Yes. FDA recognizes ASTM F1671/F1671M-22 as recognition 6-488, entered 2023-05-29.
Recognized editions of ASTM F1671
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 6-488 | ASTM F1671/F1671M-22 | 2023-05-29 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F1671: 21 CFR 878.4040.
Product codes that cite ASTM F1671
5 FDA product codes cite ASTM F1671, including FYA, FYC, OEA, QPC, QSO.
- FYA Gown, Surgical
- FYC Gown, Isolation, Surgical
- OEA
- QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- QSO
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.