Clearance Summary
LIFELINER SURGICAL GLOVE received FDA 510(k) clearance under submission number K910941, sponsored by Depuy-Raynham. 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 1991-05-09.
- Submission: K910941
- Applicant / Sponsor: Depuy-Raynham
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1991-05-09
Classification & Regulation
This clearance is catalogued under FDA product code FYE and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.