Clearance Summary
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM received FDA 510(k) clearance under submission number K113233, sponsored by Shen Wei (Usa), Inc.. 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 2012-03-29.
- Submission: K113233
- Applicant / Sponsor: Shen Wei (Usa), Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2012-03-29
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.