Clearance Summary
SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES received FDA 510(k) clearance under submission number K994248, sponsored by Shinemound Enterprise, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2000-01-28.
- Submission: K994248
- Applicant / Sponsor: Shinemound Enterprise, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2000-01-28
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.