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R&C Imports LLC

US

Last updated May 26, 2026

What R&C Imports LLC makes

R&C Imports LLC manufactures nitrile examination and treatment gloves, specifically non-powdered and non-antimicrobial variants. The portfolio includes products under the brand names Axis and Luvatek, designed for medical examinations and procedures.

These devices are classified under Class I by regulatory standards 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 R&C Imports LLC manufacture?

R&C Imports LLC specializes in nitrile examination and treatment gloves that are non-powdered and non-antimicrobial. These gloves are designed for medical examinations and procedures, ensuring a barrier against contaminants while prioritizing comfort and safety for both patients and healthcare providers.

Where is R&C Imports LLC based?

R&C Imports LLC is based in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

Which regulatory registries list R&C Imports LLC’s devices?

R&C Imports LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S., ensuring transparency and traceability for healthcare professionals and regulators.

How are R&C Imports LLC’s devices classified under regulatory standards?

R&C Imports LLC’s nitrile examination and treatment gloves fall under Class I classification. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, such as single-use gloves, which are subject to general controls rather than strict pre-market approval.

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
117081780

Catalogue (5)

DeviceModel / ReferenceRegistriesClassStatus
Axis AC-200-S
FDA UDI
Class IActive
Axis AC-200-XL
FDA UDI
Class IActive
Axis AC-200-L
FDA UDI
Class IActive
Axis AC-200-M
FDA UDI
Class IActive
Luvatek GL-LTE-PF-M
FDA UDI
Class IActive

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