122 Corporation
US Last updated 23 May 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Alcohol Pad Ref K080466
What 122 Corporation makes
122 Corporation manufactures alcohol pads, which are single-use, antiseptic wipes designed for skin preparation before medical procedures or injections.
The company’s alcohol pads are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The products are intended for use in the United States.
Frequently asked questions
What types of medical devices does 122 Corporation manufacture?
122 Corporation specializes in manufacturing alcohol pads, which are single-use, antiseptic wipes. These wipes are designed specifically for skin preparation before medical procedures or injections, ensuring proper disinfection prior to contact with sterile instruments or injection sites.
Where is 122 Corporation based?
122 Corporation is based in the United States. The company’s products, including alcohol pads, are intended for use within this market.
How are the alcohol pads manufactured by 122 Corporation classified under regulatory standards?
The alcohol pads produced by 122 Corporation are classified as Class II devices under FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Are the alcohol pads from 122 Corporation listed in any regulatory registries?
Yes, the alcohol pads manufactured by 122 Corporation are listed via the FDA’s 510(k) pathway. This pathway is used for devices that are substantially equivalent to a predicate device already on the market, demonstrating that they meet the same safety and performance requirements.
Information
- Country
- US