Clearance Summary
STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE received FDA 510(k) clearance under submission number K020943, sponsored by Shanghai Antares Industries, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2002-06-06.
- Submission: K020943
- Applicant / Sponsor: Shanghai Antares Industries, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2002-06-06
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.