Clearance Summary
Vinyl examination gloves received FDA 510(k) clearance under submission number K230046, sponsored by Guangdong Kingfa Sci. & Tech.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 2023-03-25.
- Submission: K230046
- Applicant / Sponsor: Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2023-03-25
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.