FDA.reportPublic FDA data

True Comfort® Blu

Primary DI
00649531765011
Brand
True Comfort® Blu
Company
Dash Medical Gloves, Inc.
Model
TCB100XS
Device description
Chloroprene Exam Glove, Blue, Extra Small
Published
2022-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00649531765110PackageGS110In Commercial Distribution
00649531765011PrimaryGS10
00649531765219Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00649531765110006495317651106495317651100649531765110
00649531765011006495317650116495317650110649531765011
00649531765219006495317652196495317652190649531765219

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA 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 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
4142695298Compliancedepartment@dashmedical.com

Regulatory Flags#

DUNS number
194914768
Device count
100
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
00649531592112GloveUP®GUP300XS2022-09-22
00649531592129GloveUP®GUP300S2022-09-22
00649531592143GloveUP®GUP300M2022-09-22
00649531592167GloveUP®GUP300L2021-05-31
00649531592174GloveUP®GUP300XL2022-09-22
00649531596318FLEX300™FLEX300XS2025-10-23
00649531596325FLEX300™FLEX300S2025-10-23
00649531596349FLEX300™FLEX300M2025-10-23
00649531596363FLEX300™FLEX300L2025-10-23
00649531596370FLEX300™FLEX300XL2025-10-23
00649531596387FLEX300™FLEX300XXL2025-10-23
00649531042129Black Maxx® Extreme NitrileBMNE100S2025-09-09
00649531042143Black Maxx® Extreme NitrileBMNE100M2025-09-09
00649531042167Black Maxx® Extreme NitrileBMNE100L2025-09-09
00649531042174Black Maxx® Extreme NitrileBMNE100XL2025-09-09
00649531042181Black Maxx® Extreme NitrileBMNE100XXL2025-09-09
00649531202011Alasta® PROALGA200XS2025-09-09
00649531202028Alasta® PROALGA200S2025-09-09
00649531202042Alasta® PROALGA200M2025-09-09
00649531202066Alasta® PROALGA200L2025-09-09

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
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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