ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
FDA 510(k) clearance K032464 · decided 2003-08-22
Clearance details
- K-number
- K032464
- Device name
- ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
- Applicant
- Wrp Asia Pacific Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-11
- Decision date
- 2003-08-22
- Days to decision
- 11 days
- Clearance type
- Special
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Salak Tinggi, Sepang Selangor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.