510(k) K160562 ยท LZA Polymer Patient Examination Glove
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
| Applicant | Hartalega Snd. Bhd., Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Oct 13, 2016 |
| Received | Feb 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160562
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.