510(k) K162818 ยท LZA Polymer Patient Examination Glove
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
| Applicant | Hartalega Sdn Bhd, Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Jan 9, 2017 |
| Received | Oct 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162818
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.