Clearance Summary
POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO received FDA 510(k) clearance under submission number K022566, sponsored by Qingdao Bestex Rubber & Plastic Products Co., Ltd.. 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 2002-10-15.
- Submission: K022566
- Applicant / Sponsor: Qingdao Bestex Rubber & Plastic Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2002-10-15
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.