510(k) K051793 ยท KGO Surgeon'S Gloves
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)
| Applicant | Ansell Healthcare Products, LLC, Dothan AL, US |
| Decision | Substantially Equivalent, Aug 17, 2005 |
| Received | Jul 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051793
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2011 | Ansell Healthcare Products LLC ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018455, Size 5 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka
Sur Terminated |
NPD | None listed |
| Jul 18, 2011 | Ansell Healthcare Products LLC ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka
Surgica Terminated |
NPD | None listed |
| Jul 18, 2011 | Ansell Healthcare Products LLC ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018465, Size 6 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka
Sur Terminated |
NPD | None listed |
| Jul 18, 2011 | Ansell Healthcare Products LLC ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018470, Size 7, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka
Surgica Terminated |
NPD | None listed |
| Jul 18, 2011 | Ansell Healthcare Products LLC ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018475, Size 7 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka
Sur Terminated |
NPD | None listed |
| Jul 18, 2011 | Ansell Healthcare Products LLC ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018480, Size 8, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka
Surgica Terminated |
NPD | None listed |
| Jul 18, 2011 | Ansell Healthcare Products LLC ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018485, Size 8 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka
Sur Terminated |
NPD | None listed |
| Jul 18, 2011 | Ansell Healthcare Products LLC ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka
Surgica Terminated |
NPD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.