FDA.reportPublic FDA data

Radians

Primary DI
00674326398686
Brand
Radians
Company
Radians, Inc.
Model
RWG9114
Catalog number
RWG9114XL
Device description
Powder Free Latex Examination Gloves, Blue, Non Sterile. 14 Mil. Extended Cuff. Finger Textured Grip. Single Use. Size X-Large. Tested for Use with Chemotherapy Drugs 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
LYYLatex Patient Examination Glove
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10674326398683PackageGS110In Commercial Distribution
00674326398686PrimaryGS10
90674326398689Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067432639868310674326398683
00674326398686006743263986866743263986860674326398686
9067432639868990674326398689

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Width116Millimeter

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
50
Contains 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
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
00674326398952RadiansRWG9426RWG9426S2025-01-22

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Primary DI, Brand, Company table
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09001570557490Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
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