510(k) K020019 ยท KGO Surgeon'S Gloves
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
| Applicant | Wrp Asia Pacific Sdn. Bhd., Salak Tinggi, Sepang Selangor, MY |
| Decision | Substantially Equivalent, Jan 23, 2002 |
| Received | Jan 3, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2018 | WRP Asia Pacific Sdn Bhd AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 Terminated |
KGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.