Clearance Summary
UNIGLOVES received FDA 510(k) clearance under submission number K971731, sponsored by Uni-Glove (Usa), Inc.. 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 1997-08-05.
- Submission: K971731
- Applicant / Sponsor: Uni-Glove (Usa), Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1997-08-05
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.