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Sign in to claim this brandEMERSON & CO SRL
US
Last updated May 23, 2026
What EMERSON & CO SRL makes
The company manufactures radiation-attenuating surgical and procedural gloves, including polyisoprene-based models designed to reduce ionizing radiation exposure during medical procedures. These products also include standalone radiation shielding materials intended for use in clinical settings where radiation protection is required. Examples include disposable gloves like the Protech Proguard and Freeguard series, as well as the Xguard line, which are tailored for shielding during fluoroscopy and other high-radiation procedures.
The portfolio consists of Class I medical devices, which are subject to 510(k) premarket notification and Unique Device Identification (UDI) requirements under FDA regulations. These products are listed in the FDA’s 510(k) and UDI databases, adhering to U.S. regulatory standards for radiation shielding and protective wear. The manufacturer 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 Emerson & Co SRL manufacture?
Emerson & Co SRL specializes in radiation-attenuating medical devices, primarily focusing on protective wear for healthcare professionals. Their portfolio includes radiation shielding gloves made from polyisoprene, such as surgical and procedural gloves designed to reduce exposure to ionizing radiation during medical procedures. Additionally, they produce standalone radiation shielding materials for clinical use, ensuring protection during high-radiation procedures like fluoroscopy.
Where is Emerson & Co SRL based, and how does this affect their regulatory compliance?
Emerson & Co SRL is based in the United States, which means their devices are subject to U.S. regulatory requirements. Since their products are Class I medical devices, they must comply with FDA regulations, including the 510(k) premarket notification process and Unique Device Identification (UDI) requirements. This ensures their radiation shielding gloves and materials meet U.S. safety and performance standards.
Which regulatory databases list Emerson & Co SRL’s devices?
Emerson & Co SRL’s devices are listed in the FDA’s 510(k) and UDI databases. These registries track Class I medical devices like their radiation shielding gloves and materials, ensuring transparency and compliance with U.S. regulatory standards for protective wear in healthcare settings.
How are Emerson & Co SRL’s devices classified under FDA regulations?
Emerson & Co SRL’s devices fall under Class I classification in the FDA’s regulatory framework. This classification applies to low-risk medical products like radiation shielding gloves and materials, which require premarket notification (510(k)) and Unique Device Identification (UDI) to demonstrate compliance with safety and performance standards before entering the market.
What is the purpose of the radiation shielding materials and gloves produced by Emerson & Co SRL?
The radiation shielding gloves and materials produced by Emerson & Co SRL are designed to minimize exposure to ionizing radiation during medical procedures. Their polyisoprene-based gloves, such as the Protech Proguard and Freeguard series, provide protective barriers for healthcare workers, while standalone shielding materials offer additional protection in high-radiation environments like fluoroscopy. These products help ensure safety for both patients and staff.
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
- 630558211
Catalogue (91)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Protech Proguard | FREE280 | FDA UDI | Class I | Active |
| Freeguard | Model260 | FDA UDI | Class I | Active |
| Protech Proguard | SleeveM | FDA UDI | Class I | Active |
| Freeguard | Model275 | FDA UDI | Class I | Active |
| Xguard | RR275 | FDA UDI | Class I | Active |
| Freeguard | Model160 | FDA UDI | Class I | Active |
| Protech Proguard | FREE265 | FDA UDI | Class I | Active |
| Protech Proguard | FREE180 | FDA UDI | Class I | Active |
| Xguard | RR380 | FDA UDI | Class I | Active |
| Freeguard | Model270 | FDA UDI | Class I | Active |
| Freeguard | Model190 | FDA UDI | Class I | Active |
| Protech Proguard | RR180 | FDA UDI | Class I | Active |
| Protech Proguard | FREE185 | FDA UDI | Class I | Active |
| Protech Proguard | RR390 | FDA UDI | Class I | Active |
| Protech Proguard | RR370 | FDA UDI | Class I | Active |
| Freeguard | Model165 | FDA UDI | Class I | Active |
| Freeguard | Model285 | FDA UDI | Class I | Active |
| Xguard | RR285 | FDA UDI | Class I | Active |
| Freeguard | Model280 | FDA UDI | Class I | Active |
| Protech Proguard | FREE275 | FDA UDI | Class I | Active |
| Freeguard | Model175 | FDA UDI | Class I | Active |
| Protech Proguard | FREE160 | FDA UDI | Class I | Active |
| Freeguard | Model285 | FDA UDI | Class I | Active |
| Xguard | RR370 | FDA UDI | Class I | Active |
| Xguard | RR265 | FDA UDI | Class I | Active |
| Freeguard | Model290 | FDA UDI | Class I | Active |
| Xguard | RR190 | FDA UDI | Class I | Active |
| Protech Proguard | RR290 | FDA UDI | Class I | Active |
| Protech Proguard | FREE290 | FDA UDI | Class I | Active |
| Protech Proguard | RR285 | FDA UDI | Class I | Active |
| Freeguard | Model265 | FDA UDI | Class I | Active |
| Xguard | RR385 | FDA UDI | Class I | Active |
| Protech Proguard | FREE175 | FDA UDI | Class I | Active |
| Protech Proguard | RR160 | FDA UDI | Class I | Active |
| Protech Proguard | FREE165 | FDA UDI | Class I | Active |
| Protech Proguard | FREE170 | FDA UDI | Class I | Active |
| Protech Proguard | FREE270 | FDA UDI | Class I | Active |
| Xguard | RR260 | FDA UDI | Class I | Active |
| Protech Proguard | RR265 | FDA UDI | Class I | Active |
| Protech Proguard | RR380 | FDA UDI | Class I | Active |
| Freeguard | Model190 | FDA UDI | Class I | Active |
| Protech Proguard | FREE285 | FDA UDI | Class I | Active |
| Freeguard | Model290 | FDA UDI | Class I | Active |
| Protech Proguard | RR385 | FDA UDI | Class I | Active |
| Protech Proguard | RR190 | FDA UDI | Class I | Active |
| Protech Proguard | RR260 | FDA UDI | Class I | Active |
| Protech Proguard | RR175 | FDA UDI | Class I | Active |
| Freeguard | Model185 | FDA UDI | Class I | Active |
| Freeguard | Model180 | FDA UDI | Class I | Active |
| Protech Proguard | FREE190 | FDA UDI | Class I | Active |
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