FDA.reportPublic FDA data

Radians

Primary DI
10674326398959
Brand
Radians
Company
Radians, Inc.
Model
RWG9426
Catalog number
RWG9426S
Device description
Powder Free Nitrile Examination Gloves, Blue, Non Sterile, Low Dermatitis Potential. 6 Mil. Finger Textured Grip. Single Use. Size Small. 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
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10674326398959PackageGS110In Commercial Distribution
00674326398952PrimaryGS10
90674326398955Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067432639895910674326398959
00674326398952006743263989526743263989520674326398952
9067432639895590674326398955

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
Width85Millimeter

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
044600976
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10674326399796Ducks UnlimitedDU-FF1-402PC-WMDU-FF1-402PC-WM2026-01-26
10674326398607RadiansRWG9115RWG9115S2025-01-22
10674326398614RadiansRWG9115RWG9115M2025-01-22
10674326398621RadiansRWG9115RWG9115L2025-01-22
10674326398638RadiansRWG9115RWG9115XL2025-01-22
10674326398652RadiansRWG9114RWG9114S2025-01-22
10674326398669RadiansRWG9114RWG9114M2025-01-22
10674326398676RadiansRWG9114RWG9114L2025-01-22
10674326398683RadiansRWG9114RWG9114XL2025-01-22
10674326398690RadiansRWG9114RWG9114XXL2025-01-22
10674326398805RadiansRWG9413RWG9413S2025-01-22
10674326398812RadiansRWG9413RWG9413M2025-01-22
90674326398825RadiansRWG9413RWG9413L2025-01-22
10674326398836RadiansRWG9413RWG9413XL2025-01-22
10674326398850RadiansRWG9414RWG9414S2025-01-22
10674326398867RadiansRWG9414RWG9414M2025-01-22
10674326398874RadiansRWG9414RWG9414L2025-01-22
10674326398881RadiansRWG9414RWG9414XL2025-01-22
10674326398898RadiansRWG9414RWG9414XXL2025-01-22
10674326398966RadiansRWG9426RWG9426M2025-01-22

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Primary DI, Brand, Company table
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