FDA.reportPublic FDA data

McKesson

Primary DI
00612479211766
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
20-2055N
Device description
GLOVE, SURG STR POLYISOPRENE L
Published
2020-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479211773PackageGS14In Commercial Distribution
00612479211766PrimaryGS10
00612479211759Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479211773006124792117736124792117730612479211773
00612479211766006124792117666124792117660612479211766
00612479211759006124792117596124792117590612479211759

GMDN Terms#

Term, Definition table
TermDefinition
Polyisoprene surgical glove, non-powdered, non-antimicrobialA device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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.

Regulatory Flags#

DUNS number
023904428
Device count
50
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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
09001570557278Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557407Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557438Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557469Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557490Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12