FDA.reportPublic FDA data

McKesson

Primary DI
00612479199217
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
20-1380N
Device description
GLOVE, SURG STR LTX PF MICROTH
Published
2020-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00612479199217PackageGS14In Commercial Distribution
00612479199200PrimaryGS10
00612479199194Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479199217006124791992176124791992170612479199217
00612479199200006124791992006124791992000612479199200
00612479199194006124791991946124791991940612479199194

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powderedA sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; 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 both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
50
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
true
No natural rubber latex
false
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
07323190091171Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091218Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091263Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091300Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091348Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091379Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091454Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
00841277110791Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110807Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110814Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110821Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110838Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110845Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110852Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110869Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
30888277347902MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-02
30888277347926MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-02
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40080196307525MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
40080196307549MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
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40888277347916MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
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30888277417131MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417148MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
20888277417158MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417162MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
20888277417172MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417186MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01