The Ministry of Food and Drug Safety said it plans to revise its regulation on powdered surgical and medical gloves.
Under the amendment, powdered surgical and medical gloves need to receive approval, certification, and registration. The new amendment aims to limit the use of powder gloves that can cause allergic reactions to medical personnel and patients.
The ministry 식품의약품안전처 had already recommended the use of non-powder gloves to prevent any hazardous events caused by powder gloves in June last year. The recommendation came after the U.S. Food and Drug Administration’s (FDA) recommendation not to use medical gloves containing powder.
The recommendation also outlined to sterilize powdered gloves in case of use.
The FDA warned that when the powder from the gloves combines with proteins of natural rubber latex, it can cause latex allergies to the patient or the user. Also, even during surgery or diagnosis, the powder may absorb into the surgical site or the internal tissues of the human body, thereby causing inflammation, adhesion, and granuloma.
The ministry also plans to specify the definition of a disposable medical device in the upcoming amendment.
The definition will change from “a medical device intended for one-time use or in a single procedure while treating patients,” to “a medical device intended for single use to a single patient or intended for a single patient during a single procedure.”
Organizations or individuals who have inquiries regarding the amendment should submit their comments to the ministry by Jan. 16.
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