Case Study 69: Registration of Special 510(k) for Medical Gloves with FDA-USA

Company Situation

US Medical Device company that manufactures and sales No-Sterile, Blue Powder-free Nitrile Exam Gloves that are used for medical examination, wanted to commercialize in USA a new model of same gloves with a different color (purple), and was looking for regulatory affairs professional who can give them guidance on how to register the new model with FDA.

GRP Solution

GRP Regulatory Affair team in USA helped many American and foreign medical device companies register their PPE with FDA, including different categories of medical Gloves during Covid-19 pandemic. After receiving a copy of the original (traditional) 510(K) from the client, GRP performed:

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