510(k) K971360 ยท LYZ Vinyl Patient Examination Glove
SYNTEX
| Applicant | Shinemound Enterprise, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Dec 22, 1997 |
| Received | Apr 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971360
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.