510(k) K171378 ยท LZA Polymer Patient Examination Glove
Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
| Applicant | Semperit Investments Asia Pte , Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Sep 14, 2017 |
| Received | May 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171378
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.