POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM
FDA 510(k) clearance K023912 · decided 2003-02-11
Clearance details
- K-number
- K023912
- Device name
- POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM
- Applicant
- Sanrea Healthcare Private Limited
- Decision
- Substantially Equivalent
- Date received
- 2002-11-25
- Decision date
- 2003-02-11
- Days to decision
- 78 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
- Kerala, IN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.