FDA.report

Radians

Primary DI
10674326398997
Brand
Radians
Company
Radians, Inc.
Model
RWG9426
Catalog number
RWG9426XXL
Device description
Powder Free Nitrile Examination Gloves, Blue, Non Sterile, Low Dermatitis Potential. 6 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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10674326398997PackageGS110In Commercial Distribution
00674326398990PrimaryGS10
90674326398993Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1067432639899710674326398997
00674326398990006743263989906743263989900674326398990
9067432639899390674326398993

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Width125Millimeter

Storage And Handling

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

Contacts

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

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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
10674326398959RadiansRWG9426RWG9426S2025-01-22

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