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The Stronghold Group LLC

Last updated May 24, 2026

What The Stronghold Group LLC makes

The Stronghold Group LLC manufactures single-use isolation gowns made from polypropylene (PP) or polyethylene (PE) with varying sizes, including unisize options, as well as reinforced surgical gowns for non-sterile procedures. Their product line also includes non-powdered, non-antimicrobial nitrile examination gloves in multiple sizes, designed for medical and treatment use. The gowns are categorized by performance levels, such as AAMI Level 2, to meet specific barrier protection standards.

The company’s products are regulated under the US Food and Drug Administration (FDA) as Class I and Class II medical devices, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for use in healthcare settings and are subject to compliance with FDA requirements for single-use protective apparel and gloves.

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

Information

Country: US
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 080344373

Catalogue (23)

Device	Model / Reference	Registries	Class	Status
Stronghold SMS Isolation Gown (AAMI Level 2)-M	SC210M	FDA UDI	Class I	Active
Stronghold Group Nitrile Examination Glove, Powder Free-M	SHFBSNS0603M	FDA UDI	Class I	Active
Stronghold PP/PE Isolation Gown (AAMI Level 2)-Unisize	SC200U	FDA UDI	Class I	Active
Stronghold Group Nitrile Examination Glove, Powder Free-S	SHFBSNS0603S	FDA UDI	Class I	Active
Stronghold PP/PE Isolation Gown (AAMI Level 2)-L	SC200L	FDA UDI	Class I	Active
Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XL	SC300XL	FDA UDI	Class II	Active
Stronghold PP/PE Isolation Gown (AAMI Level 2)-XL	SC200XL	FDA UDI	Class I	Active
Stronghold PP/PE Isolation Gown (AAMI Level 2)-M	SC200M	FDA UDI	Class I	Active
Stronghold SMS Isolation Gown (AAMI Level 2)-S	SC210S	FDA UDI	Class I	Active
Stronghold PP/PE Isolation Gown (AAMI Level 2)-S	SC200S	FDA UDI	Class I	Active
Stronghold Group Nitrile Examination Glove, Powder Free-XL	SHFBSNS0603XL	FDA UDI	Class I	Active
Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-L	SC300L	FDA UDI	Class II	Active
Stronghold Group Nitrile Examination Glove, Powder Free-L	SHFBSNS0603L	FDA UDI	Class I	Active
Stronghold SMS Reinforced Surgical Gown (Sterile)-XXL	SC301XXL	FDA UDI	Class II	Active
LYDUS Nitrile Examination Gloves, Powder Free	FRSNS-LYDUSNTRL	FDA UDI	Class I	Active
Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-M	SC300M	FDA UDI	Class II	Active
Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XXL	SC300XXL	FDA UDI	Class II	Active
Stronghold SMS Reinforced Surgical Gown (Sterile)-L	SC301L	FDA UDI	Class II	Active
Stronghold SMS Reinforced Surgical Gown (Sterile)-M	SC301M	FDA UDI	Class II	Active
Stronghold SMS Reinforced Surgical Gown (Sterile)-XL	SC301XL	FDA UDI	Class II	Active
Stronghold SMS Isolation Gown (AAMI Level 2)-XL	SC210XL	FDA UDI	Class I	Active
Stronghold SMS Isolation Gown (AAMI Level 2)-L	SC210L	FDA UDI	Class I	Active
Stronghold SMS Isolation Gown (AAMI Level 2)-Unisize	SC210U	FDA UDI	Class I	Active

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