Clearance Summary
DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE received FDA 510(k) clearance under submission number K001432, sponsored by Shanghai PM Plastics 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 2000-07-05.
- Submission: K001432
- Applicant / Sponsor: Shanghai PM Plastics Ent. Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2000-07-05
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.