510(k) K193121 ยท LZA Polymer Patient Examination Glove
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
| Applicant | Eco Medi Glove Sdn. Bhd., Perak, MY |
| Decision | Substantially Equivalent, Mar 20, 2020 |
| Received | Nov 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193121
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.