Clearance Summary
GLOVE LEAK DETECTOR received FDA 510(k) clearance under submission number K901237, sponsored by Utah Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1990-08-21.
- Submission: K901237
- Applicant / Sponsor: Utah Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1990-08-21
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.