Clearance Summary
CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES received FDA 510(k) clearance under submission number K892246, sponsored by B Und J Instrument, 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 1989-08-21.
- Submission: K892246
- Applicant / Sponsor: B Und J Instrument, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-08-21
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.