Class Class I
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) (K223903)
Description
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) by Semperit Investments Asia Pte , Ltd. — FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK223903
Clearance Date2023-01-27
Clearance TypeSpecial
Product CodeLZA
Regulation Number880.6250