AccessGUDID - DEVICE: OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro (00057565121077)

GUDID

Device Identifier (DI) Information

Brand Name: OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro
Version or Model: 012-107
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A.M.G. Médicale Inc

Primary DI Number: 00057565121077
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207372814 *Terms of Use

Device Description: Blue, Small Packed: 100 / Box, 10 boxes / case Customer focused packaging Attractive, easy to read boxes Flexible packaging allowing vertical or horizontal merchandising increasing shop-ability while reducing shelf and storage space Ergonomic opening to avoid waste Recyclable packaging Comfortable fit Latex-free and powder-free for low allergy or dermatitis potential Beaded cuff to prevent roll-down Snug fit for good sensation and grip Meets or exceeds ASTM standards for Medical Exam gloves Ideal for use with chemicals that will compromise vinyl and latex gloves ASTM F1671 - Penetration by Blood-Borne Pathogens ASTM D6319 - Specification for Nitrile Examination Gloves for Medical Application Chemotherapy tested using ASTM D6978

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZA	Polymer Patient Examination Glove

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110981	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc4f05ce-9542-4e92-a624-29ad38d2ff19
Public Version Date: August 20, 2020
Public Version Number: 3
DI Record Publish Date: March 05, 2020