A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

Clearance Summary

A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) received FDA 510(k) clearance under submission number K153744, sponsored by A1 Glove Sdn Bhd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-08-04.

• Submission: K153744
• Applicant / Sponsor: A1 Glove Sdn Bhd
• Clearance pathway: Traditional
• Review panel: General Hospital
• Device class: Class I
• Regulation citation: 21 CFR 880.6250
• Decision date: 2016-08-04

Classification & Regulation

This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.