Clearance Summary
SURGICAL COTTON GLOVES received FDA 510(k) clearance under submission number K900425, sponsored by Allo Pro Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1990-09-07.
- Submission: K900425
- Applicant / Sponsor: Allo Pro Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1990-09-07
Classification & Regulation
This clearance is catalogued under FDA product code LYU and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.