FDA.reportPublic FDA data

Radians

Primary DI
00674326399041
Brand
Radians
Company
Radians, Inc.
Model
RWG9418
Catalog number
RWG9418XXL
Device description
Powder Free Nitrile Examination Gloves, Blue, Non Sterile, Low Dermatitis Potential. 8 Mil. Finger Textured Grip. Single Use. Size 2X-Large. Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Gastric Acid per ASTM D6978
Published
2025-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10674326399048PackageGS110In Commercial Distribution
00674326399041PrimaryGS10
90674326399044Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067432639904810674326399048
00674326399041006743263990416743263990410674326399041
9067432639904490674326399044

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Width125Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Shield gloves from direct sunlight, fluorescent light, x-rays, moisture, and ozone.
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
901-388-7776sales@radians.com

Regulatory Flags#

DUNS number
044600976
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00674326399799Ducks UnlimitedDU-FF1-402PC-WMDU-FF1-402PC-WM2026-01-26
10674326399796Ducks UnlimitedDU-FF1-402PC-WMDU-FF1-402PC-WM2026-01-26
00674326398600RadiansRWG9115RWG9115S2025-01-22
00674326398617RadiansRWG9115RWG9115M2025-01-22
00674326398624RadiansRWG9115RWG9115L2025-01-22
00674326398631RadiansRWG9115RWG9115XL2025-01-22
00674326398655RadiansRWG9114RWG9114S2025-01-22
00674326398662RadiansRWG9114RWG9114M2025-01-22
00674326398679RadiansRWG9114RWG9114L2025-01-22
00674326398686RadiansRWG9114RWG9114XL2025-01-22
00674326398693RadiansRWG9114RWG9114XXL2025-01-22
00674326398808RadiansRWG9413RWG9413S2025-01-22
00674326398815RadiansRWG9413RWG9413M2025-01-22
00674326398822RadiansRWG9413RWG9413L2025-01-22
00674326398839RadiansRWG9413RWG9413XL2025-01-22
00674326398853RadiansRWG9414RWG9414S2025-01-22
00674326398860RadiansRWG9414RWG9414M2025-01-22
00674326398877RadiansRWG9414RWG9414L2025-01-22
00674326398884RadiansRWG9414RWG9414XL2025-01-22
00674326398891RadiansRWG9414RWG9414XXL2025-01-22

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