FDA 510(k) Applications Submitted by Semperit Investments Asia PTE LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K223903 12/28/2022 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) Semperit Investments Asia PTE LTD.
K183441 12/12/2018 Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Semperit Investments Asia PTE LTD.


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