510(k) K182851 ยท LZA Polymer Patient Examination Glove
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
| Applicant | O&M Halyard, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Jun 26, 2019 |
| Received | Oct 10, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K182851
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2021 | O&M HALYARD INC HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL Open, Classified |
LZC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.