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

Primary DI
00622554050012
Brand
I-MED Nitrile Powder-Free and Latex-Free Gloves
Company
I-Med Pharma Inc
Model
5000
Catalog number
5000
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.
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QLADecontamination systems for facemasks, surgical masks, face shields, and safety glasses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLADecontamination systems for facemasks, surgical masks, face shields, and safety glasses

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00622554050005PrimaryGS10
00622554050012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00622554050005006225540500056225540500050622554050005
00622554050012006225540500126225540500120622554050012

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(514)758-9998ilan@imedpharma.com

Regulatory Flags#

DUNS number
249008772
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00622554008907I-RELIEF Hot and Cold Therapy Eye Mask089008902020-06-18
00622554050005I-MED Nitrile Powder-Free and Latex-Free Gloves500050002020-06-18
00622554051002I-MED Surgical Mask510051002020-06-18
00622554052009I-MED KN95 Respirator Mask520052002020-06-18
00622554053006I-MED Single Use Face Mask530053002020-06-18
00622554054003I-MED Protective Facshield540054002020-07-07
00622554055000I-MED Protective Isolation Gown550055002020-06-18
00622554055017I-MED Surgical Mask510051002020-06-18
00622554052016I-MED KN95 Respirator Mask520052002020-06-18
00622554051019I-MED Protective Isolation Gown550055002020-06-18
00622554057004I-MED Non-Contact Infrared digital Clinical Thermometer570057002020-06-18
00622554054010I-MED Protective Facshield540054002020-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622554050005I-MED Nitrile Powder-Free and Latex-Free GlovesI-Med Pharma IncQLA2020-06-18
00622554052009I-MED KN95 Respirator MaskI-Med Pharma IncQLA2020-06-18
00622554053006I-MED Single Use Face MaskI-Med Pharma IncQLA2020-06-18