FDA.reportPublic FDA data

McKesson

Primary DI
00612479247932
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
14-6N58C
Device description
Glove, Exam Nitrile Black LDC PF X-Large
Published
2019-08-30
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
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479247932PackageGS110In Commercial Distribution
00612479247925PrimaryGS10
00612479247918Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479247932006124792479326124792479320612479247932
00612479247925006124792479256124792479250612479247925
00612479247918006124792479186124792479180612479247918

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
023904428
Device count
230
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
20810132043714HCSConcordance Healthcare Solutions LLCQDO2026-01-30
20810132043721HCSConcordance Healthcare Solutions LLCQDO2026-01-30
00810094577964CuraplexBOUND TREE MEDICAL, LLCQDO2025-03-31
00810094577971CuraplexBOUND TREE MEDICAL, LLCQDO2025-03-31
20850061371021American Health and SafetyLabsource, Inc.QDO2025-03-27
20850061371038American Health and SafetyLabsource, Inc.QDO2025-03-27
00850020922413American Health and SafetyLabsource, Inc.QDO2024-12-13
20850020922424American Health and SafetyLabsource, Inc.QDO2024-12-13
20850020922431American Health and SafetyLabsource, Inc.QDO2024-12-13
00850020922444American Health and SafetyLabsource, Inc.QDO2024-12-13
20850020922455American Health and SafetyLabsource, Inc.QDO2024-12-13
00850020922994American Health and SafetyLabsource, Inc.QDO2024-12-13
20850045437477VirtueNephron Nitrile LLCQDO2024-12-02
00810094577797Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577803Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577827Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577841Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577858Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00304040186619Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11
00304040186633Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11
10810132043373HCSConcordance Healthcare Solutions LLCQDO2024-09-27
00841277108330Sample Pack Velvet Nitrile Exam GloveSEMPERMED USA, INC.QDO2024-09-24
20860011916691DERMADELMedzah IndustriesQDO2024-07-22
20860011917407DERMADELMedzah IndustriesQDO2024-07-22
20850045437941Nephron NitrileNephron Nitrile LLCQDO2024-04-26
10810132043045HCSConcordance Healthcare Solutions LLCQDO2024-04-15
10810132043052HCSConcordance Healthcare Solutions LLCQDO2024-04-15
10810132043069HCSConcordance Healthcare Solutions LLCQDO2024-04-15
10810132043076HCSConcordance Healthcare Solutions LLCQDO2024-04-15
00304040179017Henry ScheinHENRY SCHEIN, INC.QDO2024-03-25