Clearance Summary
VINYL EXAM GLOVE POWERED received FDA 510(k) clearance under submission number K970144, sponsored by Hiyi Export 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 1997-04-22.
- Submission: K970144
- Applicant / Sponsor: Hiyi Export Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1997-04-22
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.