510(k) K213548 ยท LZA Polymer Patient Examination Glove
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
| Applicant | Mercator Medical (Thailand), Ltd., Amphur Rattaphum, TH |
| Decision | Substantially Equivalent, Feb 21, 2022 |
| Received | Nov 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213548
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.