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Sign in to claim this brandAmerican Nitrile Operations, LLC
US
Last updated May 27, 2026
What American Nitrile Operations, LLC makes
American Nitrile Operations, LLC produces non-powdered, non-antimicrobial nitrile examination and treatment gloves designed for medical use. The portfolio includes multiple variants of gloves under the SLATE and STEELFLEX brands, intended for single-use procedures requiring barrier protection.
These products are classified as Class I medical devices under US regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company operates within the United States, adhering to applicable regulatory requirements for Class I devices.
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 American Nitrile Operations, LLC manufacture?
American Nitrile Operations, LLC specializes in nitrile examination and treatment gloves that are non-powdered and non-antimicrobial. These gloves are designed for single-use medical procedures where barrier protection is required, such as examinations or treatments where contamination risk must be minimized.
Where is American Nitrile Operations, LLC based?
The company is based in the United States. As a US-based manufacturer, it operates under the regulatory framework of the country, ensuring compliance with applicable medical device standards and requirements.
How are the devices produced by American Nitrile Operations, LLC classified under US regulations?
The devices manufactured by American Nitrile Operations, LLC are classified as Class I medical devices under US regulations. This classification applies to products considered low-risk, such as nitrile gloves, which typically do not require rigorous pre-market approval but must still meet regulatory compliance standards.
Are the devices from American Nitrile Operations, LLC listed in any regulatory registries?
Yes, the company’s devices are listed in the FDA’s 510(k) database and the Unique Device Identifier (UDI) system. These registries help track and identify medical devices to ensure transparency and traceability in the healthcare supply chain.
Why are the gloves from American Nitrile Operations, LLC classified as Class I?
The gloves are classified as Class I because they are intended for low-risk medical uses, such as barrier protection during examinations or treatments. Class I devices generally pose minimal risk to patients and users, so they undergo less stringent regulatory oversight compared to higher-risk categories, though they must still comply with applicable safety and performance standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 614-600-2655
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 118378851
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Slate | ANSL454 | FDA UDI | Class I | Active |
| Steelflex | ANST355 | FDA UDI | Class I | Active |
| Slate | ANSL453 | FDA UDI | Class I | Active |
| Steelflex | ANST353 | FDA UDI | Class I | Active |
| Steelflex | ANST352 | FDA UDI | Class I | Active |
| Steelflex | ANST354 | FDA UDI | Class I | Active |
| Slate | ANSL452 | FDA UDI | Class I | Active |
| Slate | ANSL455 | FDA UDI | Class I | Active |
| Slate | ANSL451 | FDA UDI | Class I | Active |
| Steelflex | ANST356 | FDA UDI | Class I | Active |
| Steelflex | ANST351 | FDA UDI | Class I | Active |
| Slate | ANSL456 | FDA UDI | Class I | Active |
| Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | K220825 | FDA 510(k) | Class I | Active |
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