FDA.reportPublic FDA data

McKesson

Primary DI
00612479116177
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
14-814
Device description
Exam Glove McKesson NonSterile Ivory Powder Free Stretch Vinyl Ambidextrous Smooth Not Chemo Approved Small
Published
2020-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479116177PackageGS110In Commercial Distribution
00612479116139PrimaryGS10
00612479235274Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479116177006124791161776124791161770612479116177
00612479116139006124791161396124791161390612479116139
00612479235274006124792352746124792352740612479235274

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081586MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081593MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
10889483584446AirLife™AIRLIFELYZ2025-02-14
20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
20197344098160SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098177SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098191SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
10860011916618Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916625Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916632Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916649Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916656Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10810141931265VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931272VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931289VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931296VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931302VIVIT SupplyVivit Supply LLCLYZ2024-05-18
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10097604870013Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870020Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870037Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870044Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10755676000843ADI MedicalADI MedicalLYZ2023-11-27
10755676000850ADI MedicalADI MedicalLYZ2023-11-27
10755676000867ADI MedicalADI MedicalLYZ2023-11-27
10755676001482ADI MedicalADI MedicalLYZ2023-11-27
10755676001499ADI MedicalADI MedicalLYZ2023-11-27
10755676001512ADI MedicalADI MedicalLYZ2023-11-27
10813172024609DermAssist®INNOVATIVE HEALTHCARE CORPORATIONLYZ2023-09-01