POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES— 510(k) K954462
Substantially EquivalentIntl. Trade Management Co.
FDA 510(k) clearance K954462 for POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES, Substantially Equivalent on 1995-10-13. Applicant: Intl. Trade Management Co.. Device class: 1.
Clearance details
- Applicant
- Intl. Trade Management Co.
- 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
- Reston, VA, US
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