FDA 510(k) Applications Submitted by Kossan International Sdn Bhd

FDA 510(k) Number Submission Date Device Name Applicant
K230573 03/01/2023 Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) Kossan International Sdn Bhd
K232461 08/15/2023 Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Kossan International Sdn Bhd


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