FDA.report

McKesson

Primary DI
00612479217553
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
14-6NPNK2
Device description
Nitrile Exam Gloves POWDER-FREE TEXTURED | NON-STERILE Small
Published
2020-07-10
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
00612479217553PackageGS110In Commercial Distribution
00612479217546PrimaryGS10
00612479236042Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479217553006124792175536124792175530612479217553
00612479217546006124792175466124792175460612479217546
00612479236042006124792360426124792360420612479236042

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
023904428
Device count
250
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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Primary DIBrandModelCatalogPublished
00612479282179McKesson16-4839-22026-03-17
00612479124448McKesson16-71312026-03-11
00612479124455McKesson16-71322026-03-11
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00612479185388McKesson70-1121MCK2026-03-11
00612479185395McKesson70-1122MCK2026-03-11
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40612479262162McKesson18-3300M2026-02-23
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10612479281582McKesson181-342252026-02-06
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00612479278370McKesson16-61482026-01-26
00612479278387McKesson16-61682026-01-26
00612479278431McKesson16-618102026-01-26

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