FDA.reportPublic FDA data

Wise Choice

Primary DI
00810073734838
Brand
Wise Choice
Company
Vanguard International Solutions, LLC
Model
52023
Device description
Nitrile Powder-Free Exam Gloves - LG
Published
2024-08-23
Public version status
New
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
K170136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170136000Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Feiyang Professional Gloves Co., Ltd.2017-08-25LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810073734845PackageGS1100In Commercial Distribution
00810073734852PackageGS110In Commercial Distribution
00810073734838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810073734845008100737348458100737348450810073734845
00810073734852008100737348528100737348520810073734852
00810073734838008100737348388100737348380810073734838

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
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
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
00810073734968Wise Choice341032024-08-08

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Primary DI, Brand, Company table
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00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
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00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
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00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
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00860010400906LuvatekR&C Imports LLCLZA2026-07-29