Clearance Summary
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) received FDA 510(k) clearance under submission number K092109, sponsored by Zhangjiangang All Fine Rubber-Plastic Products Co.. 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 2009-10-09.
- Submission: K092109
- Applicant / Sponsor: Zhangjiangang All Fine Rubber-Plastic Products Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2009-10-09
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.