ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC
FDA 510(k) clearance K932665 · decided 1993-12-22
Clearance details
- K-number
- K932665
- Device name
- ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC
- Applicant
- Smith & Nephew Perry
- Decision
- Substantially Equivalent
- Date received
- 1993-06-02
- Decision date
- 1993-12-22
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Massillon, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.