FDA.reportPublic FDA data

True Comfort®

Primary DI
00649531766131
Brand
True Comfort®
Company
Dash Medical Gloves, Inc.
Model
TC100M
Device description
Chloroprene Exam Glove, Green, Medium
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
00649531766131PackageGS110In Commercial Distribution
00649531766032PrimaryGS10
00649531766230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00649531766131006495317661316495317661310649531766131
00649531766032006495317660326495317660320649531766032
00649531766230006495317662306495317662300649531766230

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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00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
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00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31