FDA 510(k) Premarket Notification K112610: SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)

Submission Details & Decision

Normalized public record details for 510(k) notification K112610.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K112610

Applicant / Sponsor

Inpro Technology Device Factory

Device Name

SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)

Product Code

LYZ

Decision Date

2011-12-05

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General Hospital (HO)

Clearance Type

Traditional

Third Party Flag

Date Received

2011-09-07

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