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Dash Medical Gloves, Inc.

US

Last updated May 24, 2026

What Dash Medical Gloves, Inc. makes

Dash Medical Gloves, Inc. manufactures single-use examination and treatment gloves in nitrile, hevea-latex, vinyl, and polychloroprene materials, all non-powdered and non-antimicrobial. The portfolio includes products like Black Maxx® Nitrile, True Comfort®, and Alasta® Shimmer Pink®, designed for medical and clinical use. Variants such as BLU200™ and VitalGard® Nitrile 200 cater to specific performance needs, including extended wear and enhanced tactile sensitivity.

All listed devices fall under FDA Class I regulation, with authorisation records maintained through 510(k) clearances and Unique Device Identifiers (UDIs). The products are registered in the FDA’s database for compliance tracking and traceability. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Dash Medical Gloves, Inc. manufacture?

Dash Medical Gloves, Inc. specializes in single-use examination and treatment gloves for medical and clinical settings. Their portfolio includes gloves made from nitrile, hevea-latex, vinyl, and polychloroprene materials. All products are non-powdered and non-antimicrobial, designed to meet common medical needs like patient examinations, treatments, and procedures. Examples include Black Maxx® Nitrile, True Comfort®, and Alasta® Shimmer Pink®, each tailored for specific performance requirements.

Where is Dash Medical Gloves, Inc. based, and how does that affect its devices?

Dash Medical Gloves, Inc. is based in the United States. This location means their devices are subject to U.S. regulatory standards, including compliance with the FDA’s requirements for medical devices. The company’s products are registered in the FDA’s database, ensuring traceability and adherence to U.S. manufacturing and quality guidelines.

Which regulatory registries list Dash Medical Gloves, Inc.’s devices?

Dash Medical Gloves, Inc.’s devices are listed in the FDA’s 510(k) clearance registry and the Unique Device Identifier (UDI) database. These registries track authorisation records and ensure compliance with FDA requirements for Class I devices, which include their gloves. The UDI system also supports traceability and transparency in the supply chain.

How are Dash Medical Gloves, Inc.’s devices classified by the FDA?

All of Dash Medical Gloves, Inc.’s devices fall under FDA Class I regulation. This classification applies to low-risk medical devices like single-use gloves, which are generally considered safe and effective when used as intended. Class I devices typically require less stringent premarket review, but they must still comply with FDA registration, listing, and labeling requirements to ensure safety and performance.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
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Phone
414-269-5298
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
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DUNS Number
194914768

Catalogue (153)

Page 2 of 4
DeviceModel / ReferenceRegistriesClassStatus
AloePRO™ Synthetic APS100L
FDA UDI
Class IActive
Black Maxx® Nitrile BMN100S
FDA UDI
Class IActive
Alasta® PRO ALGA200M
FDA UDI
Class IActive
Hi-Risk Protector™ Nitrile HRP50XL
FDA UDI
Class IActive
VitalGard® Black Nitrile VBN100XS
FDA UDI
Class IActive
Hi-Risk Protector™ Nitrile HRP50XXL
FDA UDI
Class IActive
Alasta® Shimmer Pink® PNK100XS
FDA UDI
Class IActive
True Comfort® TC100XL
FDA UDI
Class IActive
Flex200™ FLEX200XS
FDA UDI
Class IActive
VitalGard® Vinyl VV100M
FDA UDI
Class IActive
Black Maxx® Thin Nitrile BMNT200M
FDA UDI
Class IActive
Alasta® ALS100L
FDA UDI
Class IActive
Blu200™ BLU200M
FDA UDI
Class IActive
Nitrile PF NPF100L
FDA UDI
Class IActive
Flex200™ FLEX200S
FDA UDI
Class IActive
Blu100™ BLU100S
FDA UDI
Class IActive
Vinyl PF SPF100S
FDA UDI
Class IActive
Nitrile PF with Aloe NA100XL
FDA UDI
Class IActive
True Comfort® Blu TCB100S
FDA UDI
Class IActive
Nuvo™ NV100L
FDA UDI
Class IActive
Hi-Risk Protector™ Nitrile HRP50S
FDA UDI
Class IActive
Futura® FPH100XL
FDA UDI
Class IActive
Alasta® ALS100XL
FDA UDI
Class IActive
Alasta® PRO ALGA200L
FDA UDI
Class IActive
True Comfort® Blu TCB100XL
FDA UDI
Class IActive
Vinyl PF SPF100M
FDA UDI
Class IActive
Alasta® 200 ALS200XS
FDA UDI
Class IActive
Flex200™ FLEX200M
FDA UDI
Class IActive
VitalGard® Latex VPF100L
FDA UDI
Class IActive
VitalGard® Latex VPF100S
FDA UDI
Class IActive
GloveUP® GUP300M
FDA UDI
Class IActive
VitalGard® Vinyl VV100L
FDA UDI
Class IActive
Alasta® PRO ALGA200XS
FDA UDI
Class IActive
Alasta® Aloe AA100S
FDA UDI
Class IActive
Flex100™ FLEX100L
FDA UDI
Class IActive
AloePRO™ Synthetic APS100XL
FDA UDI
Class IActive
Vinyl PF SPF100XL
FDA UDI
Class IActive
Alasta® White AW100M
FDA UDI
Class IActive
Alasta® White AW100L
FDA UDI
Class IActive
Blu100™ BLU100L
FDA UDI
Class IActive
Black Maxx® Thin Nitrile BMNT200S
FDA UDI
Class IActive
True Comfort® TC100XS
FDA UDI
Class IActive
GloveUP® GUP300XL
FDA UDI
Class IActive
Alasta® ALS100S
FDA UDI
Class IActive
Alasta® Shimmer Pink® PNK100S
FDA UDI
Class IActive
Blu200™ BLU200S
FDA UDI
Class IActive
Flex200™ FLEX200L
FDA UDI
Class IActive
AloePRO™ AP100XL
FDA UDI
Class IActive
VitalGard® Nitrile VNPF100XS
FDA UDI
Class IActive
Black Maxx® Extreme Nitrile BMNE100XL
FDA UDI
Class IActive

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