FDA.report

CARDINAL HEALTH

Primary DI
20885380136631
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
N8832
Catalog number
N8832
Device description
Nitrile Exam Gloves Sterile Pairs
Published
2019-02-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LZCPatient examination glove, specialty

Product Code Classifications

CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380136632PackageGS15Not in Commercial Distribution
20885380136631PrimaryGS10
10885380136634Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088538013663250885380136632
2088538013663120885380136631
1088538013663410885380136634

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
Radiation Sterilization

Regulatory Flags

DUNS number
961027315
Device count
40
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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