510(k) K201531 ยท LZA Polymer Patient Examination Glove
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
| Applicant | Hartalega Sdn Bhd, Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Aug 5, 2020 |
| Received | Jun 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201531
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.