510(k) K212613 ยท LZA Polymer Patient Examination Glove
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
| Applicant | Koon Seng Sdn Bhd, Tangkak, MY |
| Decision | Substantially Equivalent, Dec 21, 2021 |
| Received | Aug 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212613
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.