510(k) K190080 ยท LZA Polymer Patient Examination Glove
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
| Applicant | Comfort Rubber Gloves Industries Sdn. Bhd., Matang, MY |
| Decision | Substantially Equivalent, Jun 27, 2019 |
| Received | Jan 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190080
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.