FDA.reportPublic FDA data

MocareHealth

Primary DI
06930518036816
Brand
MocareHealth
Company
Shanghai Motex Healthcare Co.,Ltd.
Model
723560
Device description
Nitrile Medical Examination Gloves, powder-free, blue color, latex-free, 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
36930518036817PackageGS110In Commercial Distribution
06930518036816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3693051803681736930518036817
06930518036816069305180368166930518036816

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
530438738
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06930518036854MocareHealth7235802020-06-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
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00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
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00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
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