Clearance Summary
DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES received FDA 510(k) clearance under submission number K040828, sponsored by Zibo Borui Plastic & Rubber 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 2004-04-19.
- Submission: K040828
- Applicant / Sponsor: Zibo Borui Plastic & Rubber Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2004-04-19
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.