510(k) K192954 ยท LZA Polymer Patient Examination Glove
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
| Applicant | Comfort Rubber Gloves Industries Sdn. Bhd., Matang, MY |
| Decision | Substantially Equivalent, Jun 19, 2020 |
| Received | Oct 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192954
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.