Clearance Summary
STERILE POWDER-FREE LATEX EXAMINATION GLOVES received FDA 510(k) clearance under submission number K980803, sponsored by Kenwell International , 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 1998-04-03.
- Submission: K980803
- Applicant / Sponsor: Kenwell International , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1998-04-03
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.