FDA.reportPublic FDA data

VGUARD

Primary DI
00850001981392
Brand
VGUARD
Company
Vanguard International Solutions, LLC
Model
A11A12
Device description
Nitrile Powder Free Exam Gloves - Medium
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092874000POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVESQuality Gallant Sdn. Bhd.2010-06-22LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001981392PackageGS1100In Commercial Distribution
00850001981408PackageGS110In Commercial Distribution
00850001981385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001981392008500019813928500019813920850001981392
00850001981408008500019814088500019814080850001981408
00850001981385008500019813858500019813850850001981385

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

Contacts#

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

Regulatory Flags#

DUNS number
093129027
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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00366975065513Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
00850084857331MedClickMedClick LLCLZA2026-07-22
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