FDA.reportPublic FDA data

Neoshield Polychloroprene Examination Gloves

Primary DI
TQ26PC102
Brand
Neoshield Polychloroprene Examination Gloves
Company
TOP QUALITY MANUFACTURING, INC.
Model
PC10
Catalog number
PC10
Device description
Polychloroprene Gloves Not made with Natural Rubber Latex Examination Gloves Color Green Size S
Published
2023-03-06
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
OPCPowder-Free Polychloroprene Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPCPowder-Free Polychloroprene Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TQ26PC102PackageHIBCC10In Commercial Distribution
TQ26PC101PrimaryHIBCC0
TQ26PC100Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA non-sterile device made of polychloroprene (neoprene) 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 talcum powder and it does not have antimicrobial features. 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 483-8559yvette@topqualitygloves.com

Regulatory Flags#

DUNS number
113630649
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00889813067994Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068007Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068021Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068038Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
00889813068045Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCOPC2026-02-12
D6620705854632Patterson®PATTERSON DENTAL SUPPLY, INC.OPC2024-11-11
D6620705854630Patterson®PATTERSON DENTAL SUPPLY, INC.OPC2024-11-11
10850002458173Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
10850002458180Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
10850002458197Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00371347010909Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00371347011258Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
10371347011255Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00850002458176Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
00850002458190Advance Dental ProductsThe Atlanta Dental Supply CompanyOPC2023-12-05
30813172023095Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
30813172023118Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
30813172023132Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
40813172023122Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
40813172023092Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
40813172023115Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
00813172023131Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
50813172023129Pulse® CR PinkINNOVATIVE HEALTHCARE CORPORATIONOPC2023-09-01
TQ26PC001Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC101Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC301Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC401Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PC501Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PCP001Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06
TQ26PCP101Neoshield Polychloroprene Examination GlovesTOP QUALITY MANUFACTURING, INC.OPC2023-03-06