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Sign in to claim this brandVallen Distribution, Inc.
US
Last updated May 25, 2026
What Vallen Distribution, Inc. makes
Vallen Distribution, Inc. manufactures utility gloves designed for medical and industrial applications, including the Specfit line. These gloves are intended to provide protection and ergonomic support for healthcare professionals and workers in environments requiring durable, flexible handwear.
The company’s utility gloves fall under FDA’s Class I device classification and are listed in the FDA’s Unique Device Identifier (UDI) database. The products are regulated under U.S. medical device laws, with compliance requirements aligned with FDA standards.
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 Vallen Distribution, Inc. manufacture?
Vallen Distribution, Inc. specializes in utility gloves, specifically the Specfit line. These gloves are designed for both medical and industrial use, offering protection and ergonomic support for users in demanding environments.
Where is Vallen Distribution, Inc. based?
Vallen Distribution, Inc. is based in the United States. The company’s products are developed and distributed from this location.
Which regulatory registries list Vallen Distribution, Inc.’s devices?
Vallen Distribution, Inc.’s utility gloves, including the Specfit line, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices under U.S. regulatory oversight.
How are Vallen Distribution, Inc.’s devices classified under FDA regulations?
The utility gloves produced by Vallen Distribution, Inc., such as the Specfit line, are classified as Class I devices by the FDA. This classification applies to devices posing minimal risk, requiring general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 782807804
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