Recognized standard
PB70:2022
FDA recognition 6-487 · ANSI · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-487 |
|---|---|
| Designation | PB70:2022 |
| Title | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| Standards developer | American National Standards Institute |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 29, 2023 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | Establishes minimum barrier performance requirements, a classification system, and associated labeling requirements for protective apparel, surgical drapes, and drape accessories intended for use in health care facilities. |
At a glance
- 10–99 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: