In the current scenario of COVID-19, Gloves (heavy duty, examination or surgical) are considered as few of the critical products for immediate supply. But with the decline in the global supply chain of gloves, meeting the demand right on time would be challenging.
To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent glove (heavy duty, examination or surgical) manufacturer you might be willing to market your product across the globe or to be specific in the USA. But do you know how gloves are classified in the USA by the United States Food and Drug Administration (US FDA)? How the US FDA regulates gloves?
Have all your questions answered regarding:
- Heavy Duty /Examination/Surgical Gloves Registration/Notification in the USA
- US FDA Gloves Regulations
- Gloves GMP as per US FDA
In addition, some global health authorities have already expedited their Regulatory pathways for gloves (either surgical, heavy duty or examination). The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline gloves global market entry with the best of regional Regulatory information and structural Regulatory approach.
As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track registration/notification of gloves in the USA.