510(k) K142805 ยท LZA Polymer Patient Examination Glove
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
| Applicant | Hartalega Sdb. Bhd., Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Dec 18, 2014 |
| Received | Sep 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142805
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.