Recognized standard
D6978-05(2023)
FDA recognition 6-147 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-147 |
|---|---|
| Designation | D6978-05(2023) |
| Title | Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 1 |
| Scope (excerpt) | 1.1 This practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the… |
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: