FDA.reportPublic FDA data

Toptolife

Primary DI
10850036987090
Brand
Toptolife
Company
Toptolife, LLC
Model
141404052
Catalog number
141404052
Device description
Nitrile Exam Gloves, Nitrile Extended Cuff, S
Published
2022-12-07
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
K171873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171873000Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy DrugsZhonghong Pulin Medical Products Co., Ltd.2017-11-15LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850036987097PackageGS110In Commercial Distribution
10850036987090PrimaryGS10
00850036987093Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085003698709720850036987097
1085003698709010850036987090
00850036987093008500369870938500369870930850036987093

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
118666048
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850036987281Toptolife1413041011413041012023-05-03
00850036987284Toptolife1413041011413041012023-05-03
10850036987021Toptolife1414040211414040212022-12-07
10850036987038Toptolife1414040221414040222022-12-07
10850036987045Toptolife1414040231414040232022-12-07
10850036987052Toptolife1414040241414040242022-12-07
10850036987069Toptolife1414040251414040252022-12-07
10850036987076Toptolife1414040261414040262022-12-07
10850036987083Toptolife1414040511414040512022-12-07
10850036987106Toptolife1414040531414040532022-12-07
10850036987113Toptolife1414040541414040542022-12-07
10850036987120Toptolife1414040551414040552022-12-07
10850036987137Toptolife1414040611414040612022-12-07
10850036987144Toptolife1414040621414040622022-12-07
10850036987151Toptolife1414040631414040632022-12-07
10850036987168Toptolife1414040641414040642022-12-07
10850036987175Toptolife1414040651414040652022-12-07
10850036987182Toptolife1414040711414040712022-12-07
10850036987199Toptolife1414040721414040722022-12-07
10850036987205Toptolife1414040731414040732022-12-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
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00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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