NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED
FDA 510(k) clearance K051563 · decided 2005-06-20
Clearance details
- K-number
- K051563
- Device name
- NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED
- Applicant
- Terang Nusa Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2005-06-13
- Decision date
- 2005-06-20
- Days to decision
- 7 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
- Kota Bharu, Kelantan, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natura recall (Z-0365-2007) | Terang Nusa Sdn Bhd | 2007-01-25 |