FDA 510(k) Premarket Notification K024216: TOP GLOVE VINYL EXAMINATION GLOVE

Submission Details & Decision

Normalized public record details for 510(k) notification K024216.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K024216

Applicant / Sponsor

Top Glove (Zhangjiagang) Co. , Ltd.

Device Name

TOP GLOVE VINYL EXAMINATION GLOVE

Product Code

LYZ

Decision Date

2003-02-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General Hospital (HO)

Clearance Type

Traditional

Third Party Flag

Date Received

2002-12-23

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