Clearance Summary
SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES received FDA 510(k) clearance under submission number K010247, sponsored by Shanghai China Star Corp. 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 2001-02-06.
- Submission: K010247
- Applicant / Sponsor: Shanghai China Star Corp
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2001-02-06
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.