China NMPA Product Recall - Disposable surgical gowns

Nanchang Demeikang Medical Device Co., Ltd. has initiated a voluntary Class III recall of its disposable surgical gowns. This action, published by the National Medical Products Administration (NMPA) on July 29, 2019, stems from the discovery that the gowns failed to meet required standards, specifically concerning their non-critical water resistance. The company voluntarily reported this issue, leading to the recall of products under Registration Certificate No.: Ganxiezhuzhun 20182640090.The primary issue identified was the non-compliance of the disposable surgical gowns with established performance criteria for water resistance. This deviation from quality standards prompted the company's proactive measure to remove the affected products from the market. As part of this regulatory action, Nanchang Demeikang Medical Device Co., Ltd. is required to provide detailed information regarding the specific models, specifications, and batches impacted by the recall in an official Medical Device Recall Event Report Form. This voluntary recall underscores the regulatory oversight by the NMPA in ensuring the quality and safety of medical devices in the market.