FDA.report

McKesson

Primary DI
00612479249646
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
14-6N66C
Device description
Glove, Exam Nitrile Blue CONFIDERM 6.8C PF Large 9” CUFF
Published
2019-10-22
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

Product Codes

CodeName
LZCPatient Examination Glove, Specialty

Product Code Classifications

CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479249646PackageGS110In Commercial Distribution
00612479249639PrimaryGS10
00612479249622Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479249646006124792496466124792496460612479249646
00612479249639006124792496396124792496390612479249639
00612479249622006124792496226124792496220612479249622

GMDN Terms

TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile 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
023904428
Device count
100
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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