510(k) K180645 ยท LZA Polymer Patient Examination Glove
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
| Applicant | Hartalega Sdn Bhd, Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Mar 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180645
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.