Clearance Summary
VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) received FDA 510(k) clearance under submission number K891567, sponsored by Neo-Sigma, 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 1989-04-11.
- Submission: K891567
- Applicant / Sponsor: Neo-Sigma, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-04-11
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.