Mauricio Menconi
AR Last updated 22 Oct 2026
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- Devices
- 2
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Ammel Patient Examination Gloves Ref K894502
Ammel Sterile Surgeon's Gloves Ref K894501
What Mauricio Menconi makes
Mauricio Menconi manufactures single-use examination gloves and sterile surgeon’s gloves, designed for medical and clinical examinations. These products are intended for barrier protection during patient contact and surgical procedures.
The company’s portfolio is regulated under FDA’s Class I device classification, with products listed via the 510(k) pathway. The manufacturer operates from the United States.
Frequently asked questions
What types of medical devices does Mauricio Menconi manufacture?
Mauricio Menconi specializes in single-use medical gloves, including patient examination gloves and sterile surgeon’s gloves. These products are designed to provide barrier protection during medical examinations and surgical procedures, ensuring hygiene and safety for both patients and healthcare providers.
Where is Mauricio Menconi based, and how does that affect its regulatory standing?
Mauricio Menconi is based in the United States. Since the company’s devices fall under FDA jurisdiction, they are regulated according to U.S. medical device laws. The location ensures compliance with FDA requirements, including classification and listing processes like the 510(k) pathway for its Class I devices.
Which regulatory registries or databases list Mauricio Menconi’s devices?
Mauricio Menconi’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class I medical devices to demonstrate substantial equivalence to a predicate device, ensuring compliance with U.S. regulatory standards before market distribution.
How are Mauricio Menconi’s gloves classified by regulatory authorities?
Mauricio Menconi’s gloves are classified as Class I medical devices by the FDA. This classification applies to products posing minimal risk, such as single-use gloves, which are generally exempt from strict pre-market approval but still require compliance with manufacturing and labeling standards to ensure safety and effectiveness.
Information
- Country
- AR