AccessGUDID - DEVICE: Coregloves (00860010506905)

GUDID

Device Identifier (DI) Information

Brand Name: Coregloves
Version or Model: CGM-LC-XS-00000000001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CGM-LC-XS-01
Company Name: SMARTLOGICS LLC

Primary DI Number: 00860010506905
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 125327611 *Terms of Use

Device Description: Medical Power Nitrile Gloves - Long Cuff - Size XS

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?
60660	Nitrile examination/treatment glove, non-powdered, 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; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe transmission/exposure and its inner surface is not covered with powder. 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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
Special Storage Condition, Specify: Store your gloves in a cool, dry place, and protect them from exposure to direct sunlight or fluorescent lighting.”

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7ee7dd4-3156-4461-b309-fd0116e2bd30
Public Version Date: November 10, 2023
Public Version Number: 4
DI Record Publish Date: September 06, 2023