Device
E-GEN Powder-Free Latex Examination Gloves, Size M, 100
Manufacturer
Genesee Scientific Holdings, LLC
Genesee Scientific Holdings, LLC
Model: 43-101M
Catalog: 43-101M
DI: 00810169610138
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-27
Current Version: 2026-05-05
Description
E-GEN Powder-Free Latex Examination Gloves, Size M, 100
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6f890d26-6745-4bd7-8bf9-de94b8cfa304
Distribution Status:
In Commercial Distribution
DUNS Number:
943016071
Device Count:
100
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
Yes
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00810169610145
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00810169610138
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00810169610138
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
10810169610135
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 47172
Name: Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Definition:
A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.
FDA Product Codes
LYY
Latex Patient Examination Glove