Recognized standard
D3577-19
FDA recognition 6-443 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-443 |
|---|---|
| Designation | D3577-19 |
| Title | Standard Specification for Rubber Surgical Gloves |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 1 |
| Scope (excerpt) | 1.1 This specification covers certain requirements for packaged sterile rubber surgical gloves used in conducting surgical procedures. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 The following safety hazards… |
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: