Clearance Summary
MODERN LATEX STERILE SURGICAL GLOVES received FDA 510(k) clearance under submission number K890073, sponsored by Modern Rubber Co., Ltd. C/O World Trade Svc.. 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 1989-01-24.
- Submission: K890073
- Applicant / Sponsor: Modern Rubber Co., Ltd. C/O World Trade Svc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1989-01-24
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.