Clearance Summary
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES received FDA 510(k) clearance under submission number K050455, sponsored by Zibo Blue Intco 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 2005-03-29.
- Submission: K050455
- Applicant / Sponsor: Zibo Blue Intco Plastic & Rubber Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2005-03-29
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.