Clearance Summary
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR received FDA 510(k) clearance under submission number K110248, sponsored by Jiangsu Dongling 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 2011-06-10.
- Submission: K110248
- Applicant / Sponsor: Jiangsu Dongling Plastic & Rubber Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2011-06-10
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.