510(k) K183280 ยท LZA Polymer Patient Examination Glove
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
| Applicant | Smart Glove Corporation Sdn. Bhd., Klang, MY |
| Decision | Substantially Equivalent, Jul 26, 2019 |
| Received | Nov 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183280
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.