FDA.reportPublic FDA data

MocareHealth

Primary DI
06930518036854
Brand
MocareHealth
Company
Shanghai Motex Healthcare Co.,Ltd.
Model
723580
Device description
Nitrile Medical Examination Gloves, powder-free, latex-free, blue color, ambidextrous, beaded cuff, textured surface in the grip area, non-sterile.
Published
2020-06-03
Public version status
Update
Distribution status
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
K030207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030207000NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735Shanghai Motex Healthcare Co., Ltd.2003-05-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36930518036855PackageGS110In Commercial Distribution
06930518036854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3693051803685536930518036855
06930518036854069305180368546930518036854

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, powderedA 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 covered with powder to facilitate donning/removal; 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Regulatory Flags#

DUNS number
530438738
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06930518002934MocareHealth6512WH55B2022-02-24
06930518002941MocareHealth6512WH60B2022-02-24
06930518002958MocareHealth6512WH65B2022-02-24
06930518002965MocareHealth6512WH70B2022-02-24
06930518002972MocareHealth6512WH75B2022-02-24
06930518002989MocareHealth6512WH80B2022-02-24
06930518002996MocareHealth6512WH85B2022-02-24
06930518003016MocareHealth6512WH90B2022-02-24
06930518003634MocareHealth6610GN55B2022-02-24
06930518003641MocareHealth6610GN60B2022-02-24
06930518003665MocareHealth6610GN65B2022-02-24
06930518003672MocareHealth6610GN70B2022-02-24
06930518003689MocareHealth6610GN75B2022-02-24
06930518003702MocareHealth6610GN80B2022-02-24
06930518003719MocareHealth6610GN85B2022-02-24
06930518003726MocareHealth6610GN90B2022-02-24
06930518032177MocareHealth1610ST852022-02-24
06930518032184MocareHealth1610ST902022-02-24
16930518002931MocareHealth6512WH55B2022-02-24
16930518002948MocareHealth6512WH60B2022-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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