Clearance Summary
LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) received FDA 510(k) clearance under submission number K891728, sponsored by Baldur Systems Corp.. 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 1989-05-25.
- Submission: K891728
- Applicant / Sponsor: Baldur Systems Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-05-25
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.