Clearance Summary
Nitrile Vinyl Blend Powder Free Examination Gloves (Black) received FDA 510(k) clearance under submission number K213574, sponsored by Grand Work Plastic 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 2022-07-12.
- Submission: K213574
- Applicant / Sponsor: Grand Work Plastic Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2022-07-12
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.