Device
Nitrile Examination Gloves Not made with Natural Rubber Latex Color Blue Fit Kit
Manufacturer
TOP QUALITY MANUFACTURING, INC.
TOP QUALITY MANUFACTURING, INC.
Model: GCNX2KSML
DI: 00369301004194
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
Nitrile Examination Gloves Not made with Natural Rubber Latex Color Blue Fit Kit
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d6ee9c45-2e11-4a8b-95fb-668eb2e6b790
Distribution Status:
In Commercial Distribution
DUNS Number:
113630649
Device Count:
1
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 - Pkg Type:
Case
Item #1 - Device ID:
10369301004191
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
200
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00369301004194
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00369301004194
Item #2 - Device ID Type:
Primary
Item #2 - 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