Clearance Summary
LATEX EXAM GLOVES-POWDER FREE received FDA 510(k) clearance under submission number K910949, sponsored by Zhongmin (Fujian) Machinery & Electrical Equipment. 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 1991-05-17.
- Submission: K910949
- Applicant / Sponsor: Zhongmin (Fujian) Machinery & Electrical Equipment
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1991-05-17
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.