Clearance Summary
Powder Free Black Nitrile Examination Glove received FDA 510(k) clearance under submission number K201428, sponsored by Vietglove Corporation. 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 2021-06-24.
- Submission: K201428
- Applicant / Sponsor: Vietglove Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-06-24
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.