Recognized standard
D6319-19(2023)
FDA recognition 6-446 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-446 |
|---|---|
| Designation | D6319-19(2023) |
| Title | Standard Specification for Nitrile Examination Gloves for Medical Application |
| 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 nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. 1.2 This specification covers nitrile rubber examination gloves that fit either hand, paired gloves, and gloves by . It also provides for… |
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: