510(k) K202078 ยท LZA Polymer Patient Examination Glove
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
| Applicant | Shen Wei USA, Inc., Union City CA, US |
| Decision | Substantially Equivalent, Mar 5, 2021 |
| Received | Jul 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202078
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.