AccessGUDID - DEVICE: Radians (00674326399027)

GUDID

Device Identifier (DI) Information

Brand Name: Radians
Version or Model: RWG9418
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RWG9418L
Company Name: Radians, Inc.

Primary DI Number: 00674326399027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 044600976 *Terms of Use

Device Description: Powder Free Nitrile Examination Gloves, Blue, Non Sterile, Low Dermatitis Potential. 8 Mil. Finger Textured Grip. Single Use. Size Large. Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Gastric Acid per 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":	Yes
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
LZC	Medical Glove, Specialty
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDO	Fentanyl And Other Opioid Protection 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: Shield gloves from direct sunlight, fluorescent light, x-rays, moisture, and ozone.
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Large
Width: 106 Millimeter

Device Record Status

Public Device Record Key: 6d6da7aa-176b-4d5a-9e50-60b280ae216d
Public Version Date: January 30, 2025
Public Version Number: 1
DI Record Publish Date: January 22, 2025