Clearance Summary
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES received FDA 510(k) clearance under submission number K964964, sponsored by Sunmax Enterprise Shanghai 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 1997-02-07.
- Submission: K964964
- Applicant / Sponsor: Sunmax Enterprise Shanghai Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1997-02-07
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.