Clearance Summary
COMFORT RUBBER GLOVES IND.SDN.BHD. received FDA 510(k) clearance under submission number K101917, sponsored by Comfort Rubber Gloves Industries 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 2010-10-29.
- Submission: K101917
- Applicant / Sponsor: Comfort Rubber Gloves Industries Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2010-10-29
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.