Recognized standard
D7160-16
FDA recognition 6-401 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-401 |
|---|---|
| Designation | D7160-16 |
| Title | Standard Practice for Determination of Expiration Dating for Medical Gloves |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 1 |
| Scope (excerpt) | 1.1 This practice covers all surgeon"s and examination gloves made from either synthetic or natural rubber latex. The purpose of this practice is to establish methods for testing medical gloves and analyzing the data to determine their shelf life. 1.2 This standard does not purport to address all 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: