510(k) K190454 ยท LZA Polymer Patient Examination Glove
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff
| Applicant | Hartalega NGC Sdn. Bhd., Bandar Sri Damansara, MY |
| Decision | Substantially Equivalent, Sep 26, 2019 |
| Received | Feb 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190454
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.