Clearance Summary
NBR Synthetic Nitrile Examination Gloves received FDA 510(k) clearance under submission number K212436, sponsored by Shandong Langtai International Trade 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 2021-12-23.
- Submission: K212436
- Applicant / Sponsor: Shandong Langtai International Trade Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-12-23
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.