Device
S-GEN Powder-Free Nitrile Examination Gloves, Size XL, 200
Manufacturer
Genesee Scientific Holdings, LLC
Genesee Scientific Holdings, LLC
Model: 44-104XL
Catalog: 44-104XL
DI: 00810169610275
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
S-GEN Powder-Free Nitrile Examination Gloves, Size XL, 200
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0abb0fda-a53d-4f4c-95b7-2a6a2e335538
Distribution Status:
In Commercial Distribution
DUNS Number:
943016071
Device Count:
200
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:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
00810169610282
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00810169610275
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00810169610275
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
10810169610272
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 56286
Name: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Definition:
A device made of nitrile 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 patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.
FDA Product Codes
LZA
Polymer Patient Examination Glove
LZC
Medical Glove, Specialty
QDO
Fentanyl And Other Opioid Protection Glove
OPJ
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs