BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
FDA 510(k) clearance K000421 · decided 2000-08-14
Clearance details
- K-number
- K000421
- Device name
- BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
- Applicant
- Ssl Americas, Inc. (Regent Medical)
- Decision
- Substantially Equivalent
- Date received
- 2000-02-08
- Decision date
- 2000-08-14
- Days to decision
- 188 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
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, recall (Z-0346-03) | SSL Americas Inc. | 2002-12-18 |