Clearance Summary
POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE received FDA 510(k) clearance under submission number K010671, sponsored by Tong Ruhn Medical Products Co., 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 2001-04-09.
- Submission: K010671
- Applicant / Sponsor: Tong Ruhn Medical Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2001-04-09
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.