Clearance Summary
UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES received FDA 510(k) clearance under submission number K000688, sponsored by N.S. Uni-Gloves Sdn. Bhd.. 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 2000-04-12.
- Submission: K000688
- Applicant / Sponsor: N.S. Uni-Gloves Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2000-04-12
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.