510(k) K001613 ยท LZA Polymer Patient Examination Glove
COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
| Applicant | Wrp Asia Pacific Sdn. Bhd., Salak Tinggi, Sepang Selangor, MY |
| Decision | Substantially Equivalent, Nov 22, 2000 |
| Received | May 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001613
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.