Clearance Summary
LATEX PATIENT EXAMINATION GLOVES received FDA 510(k) clearance under submission number K895642, sponsored by Siam Sempermed Corp., Ltd.. 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 1989-12-05.
- Submission: K895642
- Applicant / Sponsor: Siam Sempermed Corp., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1989-12-05
Classification & Regulation
This clearance is catalogued under FDA product code OPE , within the General Hospital review panel as a device.