Clearance Summary
POLY-FLEX LATEX EXAMINATION GLOVES received FDA 510(k) clearance under submission number K895499, sponsored by Pacific Delta Medical Supply. 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 1989-11-16.
- Submission: K895499
- Applicant / Sponsor: Pacific Delta Medical Supply
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-11-16
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.