510(k) K162924 ยท LZA Polymer Patient Examination Glove
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
| Applicant | Hartalega Sdb. Bhd., Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Jan 24, 2017 |
| Received | Oct 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162924
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.