Clearance Summary
Thermoplastic Elastomer (TPE) Hybrid Examination Glove received FDA 510(k) clearance under submission number K210463, sponsored by Xuzhou Full Sun Medical Products , 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 2022-01-23.
- Submission: K210463
- Applicant / Sponsor: Xuzhou Full Sun Medical Products , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2022-01-23
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.