China NMPA Product Recall - Disposable surgical gowns

On August 5, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Jiangxi Shulan Jinhuan Medical Technology Co., Ltd. The recall pertains to disposable surgical gowns manufactured by the company, identified under Registration Certificate No.: Gan Shi Yao Jian Xie (Zhun) Zi 2014 No. 2640294. The primary issue prompting this action is that the dry and wet tensile strength in key areas of these surgical gowns failed to meet established standard requirements. This deficiency is critical as it could compromise the integrity and protective capabilities of the gowns during medical procedures. Jiangxi Shulan Jinhuan Medical Technology Co., Ltd. proactively undertook this recall in response to the identified quality control failures. A Class III recall indicates that while the use of or exposure to the product is not likely to cause adverse health consequences, it still violates NMPA regulations. Further detailed information regarding specific product models, specifications, and affected batches is available in the 'Medical Device Recall Event Report Form'.