510(k) K984558 ยท KGO Surgeon'S Gloves
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
| Applicant | Ansell Perry, Massillon OH, US |
| Decision | Substantially Equivalent, Feb 26, 1999 |
| Received | Dec 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984558
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2016 | Ansell Healthcare Products LLC Gammex Non-Latex Sensitive Neoprene Surgical Gloves
Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka
Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Terminated |
KGO | None listed |
| Nov 23, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050 Terminated |
KDD | None listed |
| Jul 24, 2009 | Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri La Terminated |
KGO | None listed |
| Jul 24, 2009 | Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sr Terminated |
KGO | None listed |
| Jul 24, 2009 | Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri La Terminated |
KGO | None listed |
| Jul 24, 2009 | Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in S Terminated |
KGO | None listed |
| Jul 24, 2009 | Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri La Terminated |
KGO | None listed |
| Jul 24, 2009 | Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8517, Size 8 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sr Terminated |
KGO | None listed |
| Jul 24, 2009 | Ansell Healthcare Products LLC Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri La Terminated |
KGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.