Clearance Summary
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR received FDA 510(k) clearance under submission number K002065, 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 2000-08-22.
- Submission: K002065
- 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: 2000-08-22
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.