Clearance Summary
PATIENT EXAMINATION GLOVES received FDA 510(k) clearance under submission number K891182, sponsored by Raystar Engineering & Construction Sdn Bhd. 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 1989-11-07.
- Submission: K891182
- Applicant / Sponsor: Raystar Engineering & Construction Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-11-07
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.