China NMPA Product Recall - Medical disposable protective clothing

Zhongke Shuangying Medical Technology Co., Ltd. initiated a voluntary Class III recall for its disposable medical protective clothing (Batch No.: 20210321), as announced on July 8, 2022. This action stemmed from a random inspection conducted by the Jilin Provincial Drug Administration in Songyuan City, Jilin Province. Subsequent testing by the Jilin Provincial Medical Device Testing Institute determined that the product’s appearance and sterility did not meet the specified technical requirements outlined in its registration certificate (Gui Xie Zhu Zhun 20202140250). The regulatory framework for this recall involves provincial drug administrations operating under the National Medical Products Administration (NMPA). The company’s required action is a voluntary recall of the affected batch, with further details on model and specifications provided in the "Medical Device Recall Event Report Form" dated July 6, 2022. This ensures the removal of substandard protective clothing from use.