510(k) K210588 ยท LZA Polymer Patient Examination Glove
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
| Applicant | Onetexx Sdn Bhd, Kamunting, MY |
| Decision | Substantially Equivalent, Oct 31, 2021 |
| Received | Feb 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210588
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.