Clearance Summary
DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS) received FDA 510(k) clearance under submission number K993214, sponsored by Wrp Specialty Products Sdn. Bhd.. 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 1999-12-02.
- Submission: K993214
- Applicant / Sponsor: Wrp Specialty Products Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1999-12-02
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.