Clearance Summary
FLOW MEDICAL X-RAY PROTECTIVE GLOVES received FDA 510(k) clearance under submission number K791522, sponsored by Flow X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1979-10-26.
- Submission: K791522
- Applicant / Sponsor: Flow X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1979-10-26
Classification & Regulation
This clearance is catalogued under FDA product code KPY and 21 CFR 892.6500, within the Radiology review panel as a Class I device.