Clearance Summary
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE received FDA 510(k) clearance under submission number K090327, sponsored by Wear Safe (Malaysia) 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 2009-04-03.
- Submission: K090327
- Applicant / Sponsor: Wear Safe (Malaysia) Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2009-04-03
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.