510(k) K223903 ยท LZA Polymer Patient Examination Glove
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)
| Applicant | Semperit Investments Asia Pte , Ltd., Singapore Central, SG |
| Decision | Substantially Equivalent, Jan 27, 2023 |
| Received | Dec 28, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223903
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.