Clearance Summary
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM received FDA 510(k) clearance under submission number K000813, sponsored by Allegiance Healthcare Coporation. 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 2000-06-08.
- Submission: K000813
- Applicant / Sponsor: Allegiance Healthcare Coporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2000-06-08
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.