FDA.reportPublic FDA data

Smile 300 Blue Nitrile Examination Gloves

Primary DI
TQ26B83301
Brand
Smile 300 Blue Nitrile Examination Gloves
Company
TOP QUALITY MANUFACTURING, INC.
Model
B8330
Device description
Nitrile GlovesNot made with Natural Rubber Latex Examination GlovesColor BlueSize M
Published
2024-12-11
Public version status
New
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
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TQ26B83302PackageHIBCC10In Commercial Distribution
TQ26B83301PrimaryHIBCC0
TQ26B83300Unit of UseHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-8559regulatory@topqualitygloves.com

Regulatory Flags#

DUNS number
113630649
Device count
300
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
TQ26126092411Top Quality Manufacturing126092412024-10-30
TQ26126092431Top Quality Manufacturing126092432024-10-28
TQ26126092441Top Quality Manufacturing126092442024-10-28
TQ26126092501Top Quality Manufacturing126092502024-10-28
TQ26126092521Top Quality Manufacturing126092522024-10-28
TQ26126092531Top Quality Manufacturing126092532024-10-28
TQ26126092551Top Quality Manufacturing126092552024-10-28
TQ26126092561Top Quality Manufacturing126092562024-10-28
TQ26126092571Top Quality Manufacturing126092572024-10-28
TQ26126092581Top Quality Manufacturing126092582024-10-28
TQ26126092621Top Quality Manufacturing126092622024-10-28
TQ26126092641Top Quality Manufacturing126092642024-10-28
TQ26126092661Top Quality Manufacturing126092662024-10-28
TQ26126092681Top Quality Manufacturing126092682024-10-28
TQ26126092691Top Quality Manufacturing126092692024-10-28
TQ26126092701Top Quality Manufacturing126092702024-10-28
TQ26126092721Top Quality Manufacturing126092722024-10-28
TQ26126092731Top Quality Manufacturing126092732024-10-28
TQ26126092791Top Quality Manufacturing126092792024-10-28
TQ26126092831Top Quality Manufacturing126092832024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZC2026-07-14
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
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LZC2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LZC2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LZC2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LZC2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30