I-MED Nitrile Powder-Free and Latex-Free Gloves

Basic Information

• Brand Name: I-MED Nitrile Powder-Free and Latex-Free Gloves
• Primary DI: 00622554050005
• Version / Model: 5000
• Catalog Number: 5000
• Company Name: I-Med Pharma Inc
• Labeler DUNS: 249008772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-06-18
• Public Version: 2
• Public Version Date: 2022-10-05
• Public Version Status: Update
• Public Device Record Key: ca365096-0f17-4dbb-b910-8879324beb7e

Device Description

The I-MED Nitrile Powder-free exam gloves. Durable nitrile material is incredibly soft while providing excellent chemical resistance as well as high virus protection. Enhanced tactile sensitivity allows for accurate work with smaller items.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QLA	Decontamination systems for facemasks, surgical masks, face shields, and safety glasses
QLB	Decontamination systems for gloves, gowns, and other apparel excluding masks, respirators, face shields, safety goggles

GMDN Terms

Code	Name	Definition	Implantable	Status
56286	Nitrile examination/treatment glove, non-powdered, non-antimicrobial	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00622554050012	GS1
Primary	00622554050005	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]