Face Mask Within the Scope of the Face Mask and Barrier Face Covering Enforcement Policy or Face Mask Umbrella Eua
Which Manufacturers in China Make This?
182 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Jiangsu and Hubei, and 14 other provinces. 23 of them are contract manufacturers, able to build to a buyer’s own specification.
- Anhui Xuanwuyan Pharmaceutical Co., Ltd. Anhui
- Anji Hongde Medical Products Co., Ltd. Zhejiang, contract manufacturer
- Anji Spenq Industrial Co., Ltd. Zhejiang
- Anqing Jiaxin Medical Technology Co., Ltd. Anhui, contract manufacturer
- Arrow Medsource Group Limited contract manufacturer
- Ayida (Xiamen) P&C Technology Co., Ltd. Fujian
- Anqing Mayfield Medical Limited Anhui, contract manufacturer
- Bandex Industrial Corp. Guangdong, contract manufacturer
- Baron (China) Co., Ltd. Fujian
- Beijing Biosis Healing Biological Technology Co., Ltd. Beijing
- Beijing Zksk Technology Co., Ltd. Beijing, contract manufacturer
- Beijing Beishute Maternity & Child Articles Co., Ltd. Beijing, contract manufacturer
- Changzhou 3R Medical Device Technology Co., Ltd. Jiangsu
- Changzhou Dailys Care Products Co., Ltd. Jiangsu, contract manufacturer
- Changzhou Hongtai Paper Film Co., Ltd. Jiangsu, contract manufacturer
- Changzhou Major Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Changzhou Meiguan Care Products Technology Co., Ltd. Jiangsu
- Changzhou Recoo Healthcare Co., Ltd. Jiangsu, contract manufacturer
- Chengde Technology Co., Ltd. Zhejiang
- Chengdu Sani Medical Equipment Co., Ltd. Sichuan, contract manufacturer
- China (Shenyang) MED-Land IMP/EXP Corp., Ltd. Shanghai
- Chinamed Products (China) Ltd. Guangdong
- Conod Medical Co., Limited Jiangsu, contract manufacturer
- Crown Name Disposable Hygiene Products Fty. Ltd. Hubei, contract manufacturer
- Dalian Sundly Home Products Co., Ltd. Liaoning, contract manufacturer
- Dongguan Sengtor Plastics Products Co., Ltd. Guangdong
- Dongguan Supercare Medical Products Co., Ltd. Guangdong, contract manufacturer
- Dongguan City Ruimi Gift Products Co Ltd Guangdong
- Dongguan Mars Medical Products Co., Ltd. Guangdong
- Ecollink NON-Woven Company Limited
- Fashion Zone Co., Ltd. Zhejiang
- Foshan Nanhai Plus Medical Co Ltd Guangdong, contract manufacturer
- Foshan Niceday Sanitary Products Co., Ltd. Guangdong, contract manufacturer
- Foshan Special Medical Co., Ltd. Guangdong
- Fujian BBC Inc Fujian
- Fujian Quanzhoucity Aile Hygiene Products Co., Ltd. Fujian
- Fujian Tonggang Industries Ltd. Fujian
- Fullstar NON-Woven Products Co., Ltd. Hubei
- Fujian Hui'an Hecheng Household Products Co., Ltd. Fujian
- Guang Zhou HE Chang Optical Co., Ltd. Guangdong
- Guangdong Shunde NEW Sense Hygiene Products Co., Ltd. Guangdong
- Guangdong Ecan Medical Co., Ltd. Guangdong, contract manufacturer
- Guangdong Golden Leaves Technology Development Co., Ltd. Guangdong
- Guangdong Kangshen Medical Technology Co., Ltd. Guangdong
- Guangdong Maidi Medical Co., Ltd. Guangdong
- Guangxi Shuya Health Care-Products Co., Ltd. Guangxi, contract manufacturer
- Guangzhou Nanqixing Nonwoven Co., Ltd. Guangdong
- Guangzhou Nuoning Medical Supplies Co., Ltd. Guangdong, contract manufacturer
- Guangzhou OO Medical Scientific Limited Guangdong
- Haimen Shengbang Laboratory Equipment Co., Ltd. Jiangsu
- Hanghai Medical Products Co Ltd Zhejiang, contract manufacturer
- Hangzhou Coco Healthcare Products Co., Ltd. Zhejiang, contract manufacturer
- Hangzhou Qianzhiya Sanitary Products Co., Ltd. Zhejiang
- Hangzhou Wise Medical Device Co., Ltd. Zhejiang, contract manufacturer
- Hebei Youjie Medical Devices Co., Ltd. Hebei
- Hefei BOX Medical Innovation Co., Ltd. Anhui, contract manufacturer
- Hefei Jingcheng Plastic Products Co., Ltd. Anhui
- Henan Huibo Medical Co., Ltd. Henan, contract manufacturer
- Hengshui Gangsheng Medical Instruments Co., Ltd. Hebei, contract manufacturer
- Huaian Angel Medical Instrument Co., Ltd. Jiangsu
- Hubei Deming Healthcare Products Co., Ltd. Hubei, contract manufacturer
- Hubei Deming Healthcare Products Co., Ltd.first Branch Hubei
- Hubei Feiteng Protective Products Co., Ltd. Hubei
- Hubei Huanfu Plastic Products Co., Ltd. Hubei, contract manufacturer
- Hubei Kimsoul Industrial Co., Ltd. Hubei, contract manufacturer
- Hubei Lioncare Protective Products Co., Ltd. Hubei
- Hubei Orient International Trading Corporation Hubei
- Hubei Qifu Protective Products Co., Ltd. Hubei
- Hubei V-Medical Products Co., Ltd. Hubei, contract manufacturer
- Hubei Wanli Protective Products Co., Ltd. Hubei, contract manufacturer
- Hubei Weikang Protective Products Co., Ltd. Hubei, contract manufacturer
- Hubei Xianbao Medical Health Products Co., Ltd. contract manufacturer
- Hubei Xianmeng Health Protection Commodity.,ltd Hubei
- Hubei Yazhi Hygiene Products Co., Ltd. Hubei
- Huzhou Junda Industry Co., Ltd. Zhejiang, contract manufacturer
- Heaven Healthcare Co., Ltd. Zhejiang
- Hubei Yi-Ya Protective Products Co., Ltd. Hubei
- Hynaut Health Technology Co., Ltd. Shandong, contract manufacturer
- Insoftb(China) Co., Ltd. Fujian
- Jiangsu Huadong Medical Device Industry Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Yulong Medical Technology Co., Ltd. Jiangsu, contract manufacturer
- Jiangxi Aicare Medical Technology Co., Ltd. Jiangxi
- Jiangyin City Ruirun Clothing Co., Ltd. Jiangsu, contract manufacturer
- Jiangyin Everise Medical Equipment Co., Ltd. Jiangsu
- Jiangyin Mengjia Nonwoven Fabric Co., Ltd. Jiangsu
- Jiangyin Unixcare Medical Devices Co., Ltd. Jiangsu
- Jiaxing Xinyi Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
- Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Hubei, contract manufacturer
- Jinhua Jingdi Medical Supplies Co., Ltd. Zhejiang, contract manufacturer
- Jan Mao Industries Co., Ltd. Guangxi
- Jiangsu Guangda Medical Material Group Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Newvalue Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Jiangyin Huashi Medical Equipment Co., Ltd. Jiangsu, contract manufacturer
- Kunshan Yari Sanitary Products Co., Ltd. Jiangsu, contract manufacturer
- Lakong Medical Devices Co., Ltd. Guangdong
- Laserpair Co., Limited Guangdong, contract manufacturer
- Liaoning Bosen Medical Devices & Technologies Co., Ltd. Liaoning, contract manufacturer
- Linyi Standard Textile Co Ltd Shandong
- Llrn Personal Care (Shenzhen) Co., Ltd. Guangdong
- MDK (Shanghai) Medical Packing Co., Ltd. Shanghai, contract manufacturer
- Megasoft (China) Co., Ltd. Fujian
- Ming FAI Enterprise International Co., Ltd. Hong Kong
- Ming FAI Industrial (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
- Nan'an Hengyuan Hygiene Products Co., Ltd. Fujian
- Ningbo Chibanda IMP &EXP Co., Ltd. Zhejiang
- Ningbo Greetmed Medical Instruments Co., Ltd. Zhejiang
- Ningbo Just Soon Industrial Limited Zhejiang
- Ningbo Luke Medical Devices Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Tianbo First AID Product Co., Ltd. Zhejiang
- Ningjin Runboda Medical Protective Products Co., Ltd. Hebei
- NMS Technologies Jiangsu
- Nanjing J SUN Healthcare Co., Ltd. Jiangsu
- Ningbo Troika Science & Technology Co., Ltd. Zhejiang, contract manufacturer
- Planet (Anhui) International Co., Ltd. Anhui
- Podo Xingda (Tianjin) Medical Co., Ltd. Tianjin, contract manufacturer
- PRO-MED (Wuxi)IMP.& Exp.co., Ltd. Jiangsu
- Principle & Will Biotech (Pinghu) Co., Ltd. Zhejiang, contract manufacturer
- Qinhuangdao Taizhi Medical Technology Co., Ltd. Hebei
- Quanzhou Huifeng Sanitary Articles Co., Ltd. Fujian
- Qingdao Likangyuan Medical Device Co., Ltd. Shandong, contract manufacturer
- Quanzhou Tianjiao Lady & Baby's Hygiene Supply Co., Ltd. Fujian
- RFI Hygiene Limited Shanghai, contract manufacturer
- Rfx+care Manufacturing Co., Ltd. Zhejiang
- Riccino (Xiamen) Optical Inc. Fujian, contract manufacturer
- Safeway Industry Healthcare Hubei
- Shandong Haidike Medical Products Co., Ltd. Shandong
- Shandong Zhushi Pharmaceutical Group Co., Ltd. Shandong, contract manufacturer
- Shanghai Link Instruments Co., Ltd. Jiangsu
- Shanghai Sunwin Industry Group Co., Ltd. Shanghai
- Shenzhen Mondial Technology Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Tengda Zhichuang Technology Co., Ltd. Guangdong
- Shenzhen Youmay Electronics Co., Ltd. Guangdong
- Silverfox Corporation Limited Guangdong
- Sunkiss Healthcare(Zhejiang) Co., Ltd. Zhejiang, contract manufacturer
- Suzhou Avon Textile Co., Ltd. Jiangsu, contract manufacturer
- Suzhou Sunmed Co., Ltd. Jiangsu, contract manufacturer
- Tianjin Tairuibosi Medical Appliance Co., Ltd. Tianjin
- Tianjin Yiyi Hygiene Products Co., Ltd. Tianjin
- U-Play Products Corporation Anhui
- Vistar Medical Supplies Co., Ltd. Guangdong, contract manufacturer
- WEI SHI HAO Corporation Zhejiang
- Weihai Dishang Medical Technology Co., Ltd. Shandong, contract manufacturer
- Wellmien Healthcare Tech.(Suzhou) Co., Ltd. Jiangsu, contract manufacturer
- WEN Zhou Jinda IMP&EXP Co., Ltd. Zhejiang
- Wenzhou AIE Industry AND Trade Co., Ltd. Zhejiang
- Wenzhou Sanshan Optics Co., Ltd. Zhejiang
- Wuhan Huawei Technology Co., Ltd. Hubei, contract manufacturer
- Wuhan Lucky Star NON Woven Products Co Ltd Hubei
- Wuhan Youfu International Trade Co., Ltd. Hubei
- Wuhan Zonsen Medical Products Co., Ltd. Hubei, contract manufacturer
- Wellmed Dental Medical Supply Co., Ltd. Guangdong
- Wenzhou Shengkai Technology Industry Co., Ltd. Zhejiang
- Xiantao Daoqi Plastic Co., Ltd. Hubei, contract manufacturer
- Xiantao Generalcare Protection Products Co., Ltd. Hubei
- Xiantao Hooray Protective Products Co., Ltd. Hubei
- Xiantao Junhui Plastic Products Co., Ltd. Hubei, contract manufacturer
- Xiantao Junlong Protective Products Co., Ltd. Hubei, contract manufacturer
- Xiantao Kimberly Protective Products Co., Ltd. Hubei
- Xiantao S&J Protective Products Co., Ltd. Hubei
- Xiantao Xinfa Plastic Products Co., Ltd. Hubei, contract manufacturer
- Xiantao Xingrong Protective Products Co., Ltd. Hubei
- Xuzhou Full Sun Medical Products Ltd. Jiangsu, contract manufacturer
- Yancheng Huida Medical Instruments Co., Ltd. Jiangsu, contract manufacturer
- Yangzhou Haodi Articles OF Everyday USE Co., Ltd. Jiangsu, contract manufacturer
- Yangzhou Xinhua Brushes Co., Ltd. Jiangsu, contract manufacturer
- Yearstar Healthcare Technology Co., Ltd. Jiangsu, contract manufacturer
- Yiwu Ruoxuan Garment Co., Ltd. Zhejiang
- Yiwu Ori-Power Medtech Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Runlab Technology Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Banghaoning Medical Supplies Co., Ltd. Zhejiang
- Zhejiang Bangli Medical Products Co., Ltd. Zhejiang
- Zhejiang Excellent United Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Headway Medical Equipment Co., Ltd. Zhejiang
- Zhejiang Lidesen Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Luyao Electronics Technology Co., Ltd. Zhejiang
- Zhongshan Chukuang Textile Co., Ltd. Guangdong, contract manufacturer
- Zhuji Zhenguang Kniitting&Textile Co., Ltd. Zhejiang
- Zibo Qichuang Medical Products Co., Ltd. Shandong
- Zhangzhou iHastek Inc. Fujian
- Zhejiang E-WAY Healthcare Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Longterm Medical Technology Co., Ltd. Zhejiang, contract manufacturer
What Is This Device?
Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance, or to the Face Mask Umbrella EUA, available at https://www.fda.gov/media/137121/download
What Is FDA Product Code QKR?
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua is FDA product code QKR, not classified.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2020. None was by a company in China. The root cause the FDA records most often is No Marketing Application (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record