Clearance Summary
MULTIPLE-VINYL EXAM GLOVE, POWDERED received FDA 510(k) clearance under submission number K003133, sponsored by Excellence Ent. Co., Ltd.. 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 2000-11-07.
- Submission: K003133
- Applicant / Sponsor: Excellence Ent. Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2000-11-07
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.