Clearance Summary
Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) received FDA 510(k) clearance under submission number K182043, sponsored by Hebei Titans Hongsen Medical Technology 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 2018-09-21.
- Submission: K182043
- Applicant / Sponsor: Hebei Titans Hongsen Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2018-09-21
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.