510(k) K040503 ยท KGO Surgeon'S Gloves
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
| Applicant | Wrp Asia Pacific Sdn. Bhd., Sepang, MY |
| Decision | Substantially Equivalent, Mar 16, 2004 |
| Received | Feb 27, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2017 | Medline Industries Inc Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile.
Surgical glove. Terminated |
KGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.