Device
3.5g L Nitrile Exam Gloves 250/bx 10 bx/cs
Manufacturer
Resilient Medical Solutions, LLC
Model: RMEG4250 DI: 00850061262967 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-20 Current Version: 2026-05-28
Description
3.5g L Nitrile Exam Gloves 250/bx 10 bx/cs
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 5733e71e-8204-4edb-9e3b-696ea4ea7980
Distribution Status: In Commercial Distribution
DUNS Number: 076404432
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: No
Manufacturing Date Tracked: No
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: 10850061262964
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00850061262967
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00850061262967
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
LZC
Medical Glove, Specialty
LZA
Polymer Patient Examination Glove
QDO
Fentanyl And Other Opioid Protection Glove