Clearance Summary
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE received FDA 510(k) clearance under submission number K123469, sponsored by Wear Safe (Malaysia) Sdn Bhd - Facility II. 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 2013-02-19.
- Submission: K123469
- Applicant / Sponsor: Wear Safe (Malaysia) Sdn Bhd - Facility II
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2013-02-19
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.