Clearance Summary
Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) received FDA 510(k) clearance under submission number K163168, sponsored by Hebei Hongtai Plastic Products Company Limited. 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 2017-02-23.
- Submission: K163168
- Applicant / Sponsor: Hebei Hongtai Plastic Products Company Limited
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2017-02-23
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.