Argos S.A.
CL Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Latex Surgical Gloves Ref K890019
What Argos S.A. makes
Argos S.A. manufactures latex surgical gloves designed for use in medical procedures, ensuring barrier protection for healthcare professionals.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Argos S.A. manufacture?
Argos S.A. specializes in manufacturing latex surgical gloves. These gloves are intended to provide a protective barrier for healthcare professionals during medical procedures, helping to minimize the risk of contamination or exposure.
Where is Argos S.A. based?
Argos S.A. is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs its medical device offerings.
How are Argos S.A.’s devices classified under FDA regulations?
Argos S.A.’s latex surgical gloves fall under Class I device classification according to FDA guidelines. Class I devices are generally considered low-risk, and their regulatory pathway often involves compliance with general controls rather than pre-market approval. This classification reflects the gloves’ intended use as a straightforward protective barrier without advanced features or significant risk.
Which regulatory registries or databases list Argos S.A.’s devices?
Argos S.A.’s latex surgical gloves are listed in the FDA’s 510(k) registry. The 510(k) pathway is used for devices that are substantially equivalent to legally marketed predecessors, demonstrating compliance with FDA requirements through documentation rather than clinical trials. This listing confirms the device’s regulatory status under the U.S. system.
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