FDA 510(k) clearance · back to tracker
Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Comfort Rubber Gloves Industries Sdn. Bhd. cleared K250069 on 2025-04-29, decision: substantially equivalent
K-number
K250069
Sponsor
Comfort Rubber Gloves Industries Sdn. Bhd.
Device
Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Class
Class I
Decision
Substantially Equivalent
Decision date
2025-04-29
Product code
LYY
Advisory committee
General Hospital
Medical specialty
General Hospital
Regulation number
880.6250
Official FDA record
Open K250069on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.