AccessGUDID - DEVICE: Azur (D79010617021)

GUDID

Device Identifier (DI) Information

Brand Name: Azur
Version or Model: 1061702
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1061702
Company Name: PURELIFE, LLC

Primary DI Number: D79010617021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 828690904 *Terms of Use

Device Description: Azur Nitrile Powder-Free, Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging

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):	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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: 6b8b74e6-2a29-4861-a73c-c61ef90809e0
Public Version Date: September 01, 2020
Public Version Number: 1
DI Record Publish Date: August 24, 2020