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)

About This 510(k) Submission

K230573 is an FDA 510(k) clearance for the 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), a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Kossan International Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on June 13, 2023, 104 days after receiving the submission on March 1, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.