Clearance Summary
Examination gloves -Type C (Nitrile gloves) received FDA 510(k) clearance under submission number K212290, sponsored by Jiangxi Kemei Medical Apparatus & Instruments Group 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 2021-10-28.
- Submission: K212290
- Applicant / Sponsor: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-10-28
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.