Device recall
Z-0346-03: Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating…
FDA device recall · Class II · SSL Americas Inc.
Key facts
| Recall number (Z-number) | Z-0346-03 |
|---|---|
| Recall event | 25119 |
| Product | Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia, Regent Medical, Norcross, GA USA 30092, 1-800-843-8497, Toft Hall, Knotsford, Cheshire WA16 9PD, TEL: +44 (0) 1565 624000, Regent Medical is… |
| Product code | KGO |
| Recalling firm | SSL Americas Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2003 |
| 510(k) numbers | K000421 |
| FEI number | 3002970705 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database