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String King Lacrosse, LLC

US

Last updated May 31, 2026

What String King Lacrosse, LLC makes

String King Lacrosse, LLC manufactures single-use surgical gowns and isolation gowns designed for medical and surgical environments. They also produce non-antimicrobial and antimicrobial surgical/medical face masks, intended for disposable use in healthcare settings.

The company’s products are regulated under FDA classifications, including Class I and Class II devices. These items are listed via the FDA’s 510(k) and UDI (Unique Device Identification) systems, ensuring compliance with U.S. medical device regulations.

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 String King Lacrosse, LLC manufacture?

String King Lacrosse, LLC specializes in single-use protective wear for healthcare settings. Their primary products include surgical gowns (for sterile procedures) and isolation gowns (for infection control), both designed for one-time use. They also produce surgical and medical face masks, including both non-antimicrobial and antimicrobial variants, all intended for disposable use in clinical environments.

Where is String King Lacrosse, LLC based, and how does that affect their regulatory compliance?

String King Lacrosse, LLC is based in the United States, which means their devices are subject to U.S. Food and Drug Administration (FDA) regulations. Since they manufacture Class I and Class II devices, their products are listed through the FDA’s 510(k) premarket notification process and the Unique Device Identification (UDI) system, ensuring traceability and compliance with U.S. medical device standards.

Which regulatory registries or databases list String King Lacrosse, LLC’s devices?

String King Lacrosse, LLC’s devices are included in the FDA’s 510(k) database, which tracks premarket submissions for Class I and Class II devices, and the UDI system, which assigns unique identifiers to medical products for tracking and regulatory purposes. These registries help ensure transparency and compliance with U.S. medical device regulations.

How are String King Lacrosse, LLC’s devices classified under FDA regulations?

String King Lacrosse, LLC’s devices fall into two main FDA classification categories: Class I (generally low-risk items like some protective wear) and Class II (moderate-risk devices requiring special controls). The classification determines the regulatory pathway—such as 510(k) clearance or UDI compliance—ensuring their products meet safety and effectiveness standards before entering the market.

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

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
+1 310 795 4424
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
065807495

Catalogue (18)

DeviceModel / ReferenceRegistriesClassStatus
StringKing DIG.SMS.L2.L.BLU
FDA UDI
Class IActive
StringKing DIG.SMS.L2.XL.BLU
FDA UDI
Class IActive
StringKing 20226
FDA UDI
Class IIActive
StringKing 20224
FDA UDI
Class IIActive
StringKing 20266
FDA UDI
Class IIActive
StringKing 20267
FDA UDI
Class IIActive
StringKing 20225
FDA UDI
Class IIActive
StringKing 20221
FDA UDI
Class IIActive
StringKing 20216
FDA UDI
Class IIActive
StringKing 20227
FDA UDI
Class IIActive
StringKing 20228
FDA UDI
Class IIActive
StringKing 20214
FDA UDI
Class IIActive
StringKing 20212
FDA UDI
Class IIActive
StringKing 20222
FDA UDI
Class IIActive
StringKing 20211
FDA UDI
Class IIActive
StringKing 20218
FDA UDI
Class IIActive
Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs K202607
FDA 510(k)
Class IIActive
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue K212633
FDA 510(k)
Class IIActive

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