PETALING JAYA: Mah Sing Group Bhd’s subsidiary, Mah Sing Healthcare Sdn Bhd, has obtained 510(k) Premarket Notification clearances from the US Food and Drug Administration (FDA) to market nitrile examination gloves tested for use with chemotherapy drugs.
With the updated 510(k) clearances, Mah Sing Healthcare will be able to market medical grade examination gloves which can be used in the handling or preparation of chemotherapeutic drugs in the US market. This will enable big medical players in the US to obtain gloves from Mah Sing Healthcare as their existing suppliers also carry the chemotherapy protection claim.
Chemotherapy protection is often a critical consideration when evaluating exam gloves and healthcare workers generally use gloves that are labelled as “patient examination gloves” or “surgeon’s gloves” which carry the label “tested for use with (name of the chemotherapeutic drug or drugs). This is to prevent unknowingly exposing themselves to chemotherapy drugs that may penetrate the gloves they use. Due to the prevalence of latex allergies, chemo-tested nitrile gloves are the preferred option for chemotherapy treatment as nitrile is highly resistant against chemicals.
Chemotherapy exam-grade, also known as chemo gloves, are products that have been tested and approved to protect against chemotherapy drugs and Mah Sing Healthcare’s nitrile gloves have been tested and approved to protect against 11 chemotherapy drugs.
Chemotherapy exam-grade gloves have a specific Acceptable Quality Limit (AQL) and undergo extreme testing to ensure the proper protection against chemotherapy drugs as well as bloodborne pathogens and contaminants. Chemotherapy exam-grade gloves are non-sterile and should be used for non-surgical applications and procedures.
Mah Sing Healthcare’s glove factory has completed the commissioning of all their 12 production lines, and received the necessary certifications to market medical-grade gloves in a wide range of countries, including the US, Canada, the European Union, and the European Economic Area. With a stronger sales force and wider geographic reach, Mah Sing Healthcare is well positioned to meet the ongoing demand for gloves.
Mah Sing Healthcare’s glove factory is a highly automated plant to enhance cost effectiveness.
The company’s management said it is determined to put in place enhanced manufacturing practices and will adhere strictly to environmental, social and governance and other international regulations such as International Labour Organisation Protocols compliance. “Moving forward, Mah Sing strives to deliver high quality products while maintaining efficient, professional, and integrity services to our global importers, distributors, and customers,” it said.