Clearance Summary
Single-Use Latex Sterile Surgical Gloves (SG100) received FDA 510(k) clearance under submission number K231446, sponsored by Fitone Latex Products Co., Ltd. Guangdong. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-09-22.
- Submission: K231446
- Applicant / Sponsor: Fitone Latex Products Co., Ltd. Guangdong
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2023-09-22
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.