K250069

Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

510(k) number: K250069
Device name: Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Applicant: Comfort Rubber Gloves Industries Sdn. Bhd. MY
Product code: LYY — Latex Patient Examination Glove
Decision date: 2025-04-29
Date received: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

Also available from FDA: K250069.pdf

Official FDA record: K250069

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.