Clearance Summary
SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES received FDA 510(k) clearance under submission number K900296, sponsored by P.T. Latexindo Prautama. 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 1990-03-14.
- Submission: K900296
- Applicant / Sponsor: P.T. Latexindo Prautama
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1990-03-14
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.