Clearance Summary
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) received FDA 510(k) clearance under submission number K211667, sponsored by Changzhou Universal Medical Equipment Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2021-09-23.
- Submission: K211667
- Applicant / Sponsor: Changzhou Universal Medical Equipment Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class I
- Regulation citation: 21 CFR 862.3280
- Decision date: 2021-09-23
Classification & Regulation
This clearance is catalogued under FDA product code LAZ and 21 CFR 862.3280, within the Clinical Toxicology review panel as a Class I device.