Clearance Summary
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance under submission number K182554, sponsored by He Chuang Plastic & Rubber 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 2019-03-22.
- Submission: K182554
- Applicant / Sponsor: He Chuang Plastic & Rubber Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2019-03-22
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.