Clearance Summary
REVISED PATIENT EXAMINATION GLOVES received FDA 510(k) clearance under submission number K896411, sponsored by Pt. Trihasta Loka Persada. 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 1989-12-20.
- Submission: K896411
- Applicant / Sponsor: Pt. Trihasta Loka Persada
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-12-20
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.