Clearance Summary
B-CARE POWDER FREE LATEX EXAMINATION GLOVES received FDA 510(k) clearance under submission number K051404, sponsored by B-Care Industries 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 2005-09-27.
- Submission: K051404
- Applicant / Sponsor: B-Care Industries Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2005-09-27
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.