Clearance Summary
HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES received FDA 510(k) clearance under submission number K905086, sponsored by Hpi, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-12-03.
- Submission: K905086
- Applicant / Sponsor: Hpi, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1990-12-03
Classification & Regulation
This clearance is catalogued under FDA product code IWP and 21 CFR 892.6500, within the Radiology review panel as a Class I device.