Jiangxi Provincial Medical Products Administration Announces 8 Batches of Non-compliant Medical Devices, Including 4 Batches of Disposable Medical Masks

Economic Daily - China Economic Net, Beijing, November 10 (Reporters Zhu Guowang and Yang Qiqi) – Recently, the Jiangxi Provincial Medical Products Administration released the “Announcement on the Supervisory Sampling Inspection Information of Medical Devices, Issue No. 7, 2020,” which showed that a total of 157 batches of medical device products complied with standard requirements, among which 149 batches were qualified and 8 batches were unqualified.

The announcement indicates that, according to testing by the Jiangxi Provincial Medical Device Testing Center, the medical infrared thermometer (production date/batch number/factory serial number: 2020-3-26/20200326/) produced by Chongren County Dingfu Medical Instrument Co., Ltd. does not comply with regulations, with the non-conforming item being the temperature test range.

Protective suits manufactured by Jiangxi Guokang Industrial Co., Ltd. (Production Date/Batch Number/Factory Release Number: 2020-5-20/20200520/) were found to be non-compliant, with the failure item being sterility.

The disposable medical masks (production date/batch number/factory number: 2020-5-26/2020526/) produced by Nanchang Jiahui Medical Health Care Products Co., Ltd. do not meet the regulations, and the non-conforming item is sterility.

The medical infrared thermometer (production date/batch number/factory serial number: 2020-4-16/2020-4-16/001141/001133) manufactured by Jiangxi Guokang Industrial Co., Ltd. was found non-compliant, with the measurement range being the non-conforming item.

The disposable surgical drapes produced by Nanchang Aiyi Sanitary Material Co., Ltd. (Production Date/Batch Number/Factory Number: 2020-3-6/20200306/) did not meet the requirements, with the non-conforming item being air permeability resistance.

The disposable medical masks manufactured by Jiangxi Yikang Medical Instrument Group Co., Ltd. (Production Date/Batch Number/Factory Number: 2020-6-3/Batch 200601/) do not comply with regulations; the non-conforming items are microbial contamination and sterility.

The disposable medical masks produced by Jiangxi Haole Medical Instrument Co., Ltd. (Production Date/Batch Number/Factory Number: 2020-6-6/20200606/) do not comply with regulations, with the non-conforming item being airflow resistance.

The disposable medical masks manufactured by Jiangxi Baishikang Medical Instrument Co., Ltd. (Production Date/Batch Number/Factory Number: 2020-5-30/20200501/) did not meet the requirements, with the non-compliant item being bacterial filtration efficiency.