FDA.reportPublic FDA data

5R MED

Primary DI
06973675390063
Brand
5R MED
Company
5R MED Instruments (CHENGDU) Co., Ltd
Model
5R-GVN
Device description
Disposable Nitrle Gloves, Size: M
Published
2021-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K210776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210776000Nitrile Examination Gloves5r Med Instruments (Chengdu) Co., Ltd.2021-07-12LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973675390063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973675390063069736753900636973675390063

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554529132
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
069736753900015R MED5R-GVN2021-08-10
069736753902305R MED5R-GVN2021-08-10
069736753910085R MED5R GVN2021-08-10
069736753912135R MED5R-DM2021-08-10
069736753920365R MED5R-DM2021-08-10
069736753922415R MED5R-DM2021-08-10
069736753925625R MED5R-DM2021-08-10
069736753929205R MED5R-GVN2021-08-10
069736753930575R MED5R-GVC2021-08-10
069736753931565R MED5R-GVC2021-08-10
069736753933235R MED5R-GVC2021-08-10
069736753950065R MED5R-GV2021-08-10
069736753916955R MED5RMED 5R-GVN2021-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
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00755676002765mvetADI MedicalLZA2026-10-23
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00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
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00755676003021mvetADI MedicalLZA2026-10-23
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00755676003083mvetADI MedicalLZA2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
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00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16