SURGICAL GLOVES— 510(k) K911134
Substantially EquivalentKenwell International , Ltd.
FDA 510(k) clearance K911134 for SURGICAL GLOVES, Substantially Equivalent on 1991-07-12. Applicant: Kenwell International , Ltd.. Device class: 1.
Clearance details
- Applicant
- Kenwell International , Ltd.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Karnataka, Karnataka, IN
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