FDA.report

CARDINAL HEALTH

Primary DI
00192253064073
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
N8841XPB
Catalog number
N8841XPB
Device description
CARDINAL HEALTH GLOVE EXAM NON-STERILE NITRILE EXTENDED CUFF BLUE POWDER-FREE S FT TEXT CHEMO/LAB CHEMICAL TESTED EXT CUFF 50CT box
Published
2023-09-18
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

Product Codes

CodeName
LZAPolymer patient examination glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192253064073PackageGS110In Commercial Distribution
00885380197102PrimaryGS10
10885380197109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192253064073001922530640731922530640730192253064073
00885380197102008853801971028853801971020885380197102
1088538019710910885380197109

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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