FDA.reportPublic FDA data

True Comfort®

Primary DI
00649531766124
Brand
True Comfort®
Company
Dash Medical Gloves, Inc.
Model
TC100S
Device description
Chloroprene Exam Glove, Green, Small
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00649531766124PackageGS110In Commercial Distribution
00649531766025PrimaryGS10
00649531766223Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00649531766124006495317661246495317661240649531766124
00649531766025006495317660256495317660250649531766025
00649531766223006495317662236495317662230649531766223

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
414-269-5298compliancedepartment@dashmedical.com

Regulatory Flags#

DUNS number
194914768
Device count
100
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
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00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
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00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01