FDA.reportPublic FDA data

Midway Select

Primary DI
10843717100741
Brand
Midway Select
Company
MIDWAY DENTAL SUPPLY, LLC
Model
002-0064
Device description
Gloves Nitrile Powder-Free 4.2g X-Small, Pkg/200
Published
2019-01-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001619000MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)Multisafe Sdn. Bhd.2000-07-26LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843717100741PrimaryGS10
00843717100744Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084371710074110843717100741
00843717100744008437171007448437171007440843717100744

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
102354446
Device count
200
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10843717102547Midway Select002-02572019-07-19
10843717102721Midway Select002-02582019-07-19
10843717106699Midway Select002-04952021-04-05
10843717106705Midway Select002-04962021-04-05
10843717106712Midway Select002-04972021-04-05
10843717106729Midway Select002-04982021-04-05
10843717106736Midway Select002-04992021-04-05
10843717106743Midway Select002-05002021-04-05
10843717106750Midway Select002-05012021-04-05
10843717106767Midway Select002-05022021-04-05
10843717106774Midway Select002-05032021-04-05
10843717106781Midway Select002-05042021-04-05
10843717106798Midway Select002-05052021-04-05
10843717106804Midway Select002-05062021-04-05
10843717106811Midway Select002-05092021-04-05
10843717106828Midway Select002-05102021-04-05
10843717106835Midway Select002-05112021-04-05
10843717106842Midway Select002-05122021-04-05
10843717106859Midway Select002-05132021-04-05
10843717106866Midway Select002-05142021-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
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00850005229612NeuflexMedgluv Inc.LZA2026-06-29
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00810145951996NeuPro 16Medgluv Inc.LZA2026-06-26
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