Clearance Summary
CONFIDENCE(TM) STERILE, DISP., LATEX SURG. GLOVES received FDA 510(k) clearance under submission number K882431, sponsored by Charise Charles, Ltd.. 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 1988-12-02.
- Submission: K882431
- Applicant / Sponsor: Charise Charles, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1988-12-02
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.