Recognized standard
D3578-19(2023)
FDA recognition 6-440 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-440 |
|---|---|
| Designation | D3578-19(2023) |
| Title | Standard Specification for Rubber Examination 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 natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material. 1.2 This specification provides for natural rubber… |
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: