Clearance Summary
PROTEKT GLOVES received FDA 510(k) clearance under submission number K910920, sponsored by Intermedics Orthopedics. 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 1991-05-15.
- Submission: K910920
- Applicant / Sponsor: Intermedics Orthopedics
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1991-05-15
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.