Device recall
Z-0365-2007: Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not…
FDA device recall · Class II · Terang Nusa Sdn Bhd
Key facts
| Recall number (Z-number) | Z-0365-2007 |
|---|---|
| Recall event | 37013 |
| Product | Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia |
| Product code | KGO |
| Recalling firm | Terang Nusa Sdn Bhd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 12, 2009 |
| 510(k) numbers | K051563 |
| FEI number | 3012304897 |
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