Clearance Summary
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) received FDA 510(k) clearance under submission number K100964, sponsored by Hebei Shenzichen Plastic & Rubber Products Co., LT. 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 2010-07-16.
- Submission: K100964
- Applicant / Sponsor: Hebei Shenzichen Plastic & Rubber Products Co., LT
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2010-07-16
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.