Clearance Summary
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES received FDA 510(k) clearance under submission number K092160, sponsored by Comfort Rubber Gloves Ind. 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 2009-11-27.
- Submission: K092160
- Applicant / Sponsor: Comfort Rubber Gloves Ind. Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2009-11-27
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.