Clearance Summary
REPEL(TM) LITE CUT RESISTANT GLOVE LINERS received FDA 510(k) clearance under submission number K914077, 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 1991-12-02.
- Submission: K914077
- Applicant / Sponsor: Depuy-Raynham
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1991-12-02
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.