Recognized standard
F3352/F3352M-23b
FDA recognition 6-520 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-520 |
|---|---|
| Designation | F3352/F3352M-23b |
| Title | Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | 1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: