510(k) K211319 ยท LZA Polymer Patient Examination Glove
Purism Non-Sterile Powder Free Nitrile Examination Gloves
| Applicant | Dezhou Purism Medical Technology Co., Ltd., Dezhou, CN |
| Decision | Substantially Equivalent, Aug 19, 2021 |
| Received | Apr 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211319
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.