FDA.reportPublic FDA data

VGUARD

Primary DI
00850001981354
Brand
VGUARD
Company
Vanguard International Solutions, LLC
Model
A11A11
Device description
Nitrile Powder Free Exam Gloves - Small
Published
2022-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K092874000
K131440000
K210684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092874000POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVESQuality Gallant Sdn. Bhd.2010-06-22LZA
K131440000POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUEHebei Hongsen Plastics Technology Co, Ltd.2013-09-25LZA
K210684000Disposable Nitrile Medical Examination GloveJiangsu Cureguard Glove Co., Ltd.2021-07-20LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001981361PackageGS1100In Commercial Distribution
00850001981378PackageGS110In Commercial Distribution
00850001981354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001981361008500019813618500019813610850001981361
00850001981378008500019813788500019813780850001981378
00850001981354008500019813548500019813540850001981354

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.

Contacts#

Phone, Email table
PhoneEmail
1-866-848-2736Customersupport@vanguardsafety.com

Regulatory Flags#

DUNS number
093129027
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810052977232VGUARDA11A102024-09-22
00810052977522VGUARDA11A152024-09-22
00810052977249VGUARDA11A102024-09-22
00810052977539VGUARDA11A152024-09-22
00810073734777Wise Choice520212024-08-23
00810073734807Wise Choice520222024-08-23
00810073734838Wise Choice520232024-08-23
00810073734869Wise Choice520242024-08-23
00810073734784Wise Choice520212024-08-23
00810073734814Wise Choice520222024-08-23
00810073734845Wise Choice520232024-08-23
00810073734876Wise Choice520242024-08-23
00810073732957VGUARDA16A302024-08-08
00810073734890Wise Choice341012024-08-08
00810073734920Wise Choice341022024-08-08
00810073734951Wise Choice341032024-08-08
00810073734982Wise Choice341042024-08-08
00810073732964VGUARDA16A302024-08-08
00810073734906Wise Choice341012024-08-08
00810073734937Wise Choice341022024-08-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
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