# China NMPA Product Recall - Disposable surgical gowns

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanchang-medical-equipment-co-ltd/f2a4e612-19dd-41b5-ac68-cbb379edeb29/
Source feed: China

> China NMPA product recall for Disposable surgical gowns by Nanchang Medical Equipment Co., Ltd. published July 29, 2019. Recall level: Level 3 Recall. Nanchang Demeikang Medical Device Co., Ltd. has initiated a voluntary Class III recall of its dispos

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanchang Demeikang Medical Device Co., Ltd. voluntarily recalls disposable surgical gowns.
- Company Name: Nanchang Medical Equipment Co., Ltd.
- Publication Date: 2019-07-29
- Product Name: Disposable surgical gowns
- Recall Level: Level 3 Recall
- Recall Reason: The non-critical areas of the disposable surgical gown did not meet the standard requirements for water resistance.
- Discovering Company: Nanchang Demeikang Medical Equipment Co., Ltd.
- Manufacturing Company: Nanchang Medical Equipment Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/nanchang-medical-equipment-co-ltd/7015714e-5b20-4940-b684-b1e40cb5f2ff/