Clearance Summary
Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance under submission number K212789, sponsored by 5r Med Instruments (Chengdu) 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 2021-12-01.
- Submission: K212789
- Applicant / Sponsor: 5r Med Instruments (Chengdu) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-12-01
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.