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Uniseal

US

Last updated May 23, 2026

What Uniseal makes

Uniseal manufactures single-use examination and treatment gloves in nitrile, hevea-latex, and vinyl, all non-powdered and non-antimicrobial. The portfolio also includes textured and smooth surgical/medical face masks designed for single-use applications.

These products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Uniseal manufacture?

Uniseal specializes in single-use personal protective and examination devices. Their portfolio includes nitrile, hevea-latex, and vinyl examination and treatment gloves, all of which are non-powdered and non-antimicrobial. They also produce surgical and medical face masks, designed for single-use applications. These products are primarily used in clinical and healthcare settings to maintain hygiene and reduce infection risk.

Where is Uniseal based, and how does that affect their regulatory standing?

Uniseal is based in the United States. Since they operate within the U.S., their devices are subject to FDA regulations. The company’s products are classified under FDA’s Class I (generally low-risk) and Class II (moderate-risk) categories, meaning they undergo specific regulatory pathways to ensure compliance with safety and performance standards before entering the market.

Are Uniseal’s devices listed in any regulatory registries, and why does that matter?

Yes, Uniseal’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a standardized identifier to each device, improving traceability, reducing medical errors, and facilitating better post-market surveillance. Listing in the UDI database ensures transparency and helps healthcare providers, regulators, and manufacturers track devices throughout their lifecycle.

How are Uniseal’s gloves and masks classified by the FDA, and what does that classification mean?

Uniseal’s gloves and masks fall under FDA Class I (for lower-risk items like some gloves) and Class II (for higher-risk items like certain textured or high-performance gloves). Class I devices typically require general controls, while Class II devices may need additional performance standards or special controls. The classification determines the regulatory scrutiny and testing requirements each product must meet to ensure safety and effectiveness before commercialization.

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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LinkedIn
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Facebook
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Email
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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
782209340

Catalogue (126)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Uniseal BlackSeal ST 775-9
FDA UDI
Class IActive
Uniseal ProDerma Smooth 010-8
FDA UDI
Class IActive
Uniseal High-Risk Latex 015-0
FDA UDI
Class IActive
HandPlus Nitrile Safety 1210-6
FDA UDI
Class IActive
Uniseal Nitrile Plus X-Tend 156-6
FDA UDI
Class IActive
Uniseal BIO-NIT 422-5
FDA UDI
Class IActive
Uniseal Vinyl Care 017-7
FDA UDI
Class IActive
Uniseal ProDerma Textured 011-5
FDA UDI
Class IActive
Uniseal SureGrip Plus 039-6
FDA UDI
Class IActive
Uniseal SensiFlex 202-7
FDA UDI
Class IActive
Uniseal Nitriflex 094-6
FDA UDI
Class IActive
HandPlus Nitrile Exam 068-0
FDA UDI
Class IActive
Uniseal Bio-Nit Nitrile 422A-6
FDA UDI
Class IActive
Uniseal Nitrile Plus X-Tend 156-0
FDA UDI
Class IActive
Uniseal Unimask 711-3
FDA UDI
Class IIActive
Uniseal UniPro 702-0
FDA UDI
Class IActive
Uniseal BlackSeal HT 779-9
FDA UDI
Class IActive
Uniseal Nitrile Plus 150-9
FDA UDI
Class IActive
Uniseal High Risk Nitrile 015X-0
FDA UDI
Class IActive
Uniseal Nitriflex 094-5
FDA UDI
Class IActive
Uniseal ProDerma Smooth 010-6
FDA UDI
Class IActive
Uniseal High-Risk Latex 015-9
FDA UDI
Class IActive
Uniseal BlackSeal ST 775-0
FDA UDI
Class IActive
Uniseal Nitrile Plus X-Tend 156-9
FDA UDI
Class IActive
Uniseal Nitriflex 094-0
FDA UDI
Class IActive
HandPlus Latex Exam 061-7
FDA UDI
Class IActive
Uniseal High Risk Nitrile 015X-9
FDA UDI
Class IActive
HandPlus Nitrile Safety 1210-7
FDA UDI
Class IActive
Uniseal High-Risk Latex 015-6
FDA UDI
Class IActive
HandPlus Nitrile Exam 068-5
FDA UDI
Class IActive
Handplus Nitrile XT8 088-9
FDA UDI
Class IActive
Uniseal ProDerma Textured 011-8
FDA UDI
Class IActive
Uniseal BlackSeal 777-6
FDA UDI
Class IActive
Uniseal High-Risk Latex 015-7
FDA UDI
Class IActive
HandPlus Latex Exam 061-8
FDA UDI
Class IActive
Uniseal BlackSeal 777-9
FDA UDI
Class IActive
Uniseal BlackSeal 777-0
FDA UDI
Class IActive
Uniseal ProDerma Smooth 010-5
FDA UDI
Class IActive
HandPlus Nitrile Exam 068-7
FDA UDI
Class IActive
Uniseal Nitriflex 094-7
FDA UDI
Class IActive
Uniseal SureGrip Plus 039-7
FDA UDI
Class IActive
Uniseal UniFlex 103-6
FDA UDI
Class IActive
Uniseal BlackSeal 777-7
FDA UDI
Class IActive
Uniseal BIO-NIT 422-6
FDA UDI
Class IActive
Uniseal SureGrip 035-8
FDA UDI
Class IActive
Uniseal BlackSeal LT 774-8
FDA UDI
Class IActive
Uniseal BlackSeal HT 779-0
FDA UDI
Class IActive
Uniseal Nitrile Plus 150-7
FDA UDI
Class IActive
HandPlus Latex Exam 061-6
FDA UDI
Class IActive
Uniseal High Risk Nitrile 015X-8
FDA UDI
Class IActive

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