89-18
Filtering Facepiece Respirators (FFR)
33 firms from 1 country are named on this alert. Their shipments may be detained at the port without physical examination. The oldest listing here dates to 7 July 2020, the newest to 22 June 2021.
- 33firms listed
- 1country
- 31 May 2025alert last published
- Source on FDA →accessdata.fda.gov
Why FDA issued it
NOTE: The revision of this Import Alert (IA) dated 12/20/2022 updates the guidance section. Changes to the import alert are bracketed by asterisks (***). A Filtering Facepiece Respirator (FFR) is a device that is a disposable half-face-piece non-powered air-purifying respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. An example of a disposable FFR that is classified as a medical device is an N95 respirator intended for use in a health care setting by healthcare personnel (HCP) or other wearers. FFRs that are devices must be FDA-cleared, exempt from 510(k), or authorized under an emergency use authorization (EUA). On January 31, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to COVID-19. FDA had issued three EUAs that authorized c
Quoted from the “Reason for Alert” section of the FDA page for 89-18, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.
Firms named on 89-18
| Firm | Country | Listed since | |
|---|---|---|---|
| ANSHUN HEALTH AND MEDICAL TECHNOLOGY CO LTDE6 Bldg Ind Sci And Tech Park , Xixiu , Anshun, Guizhou CHINA | China | 31 Jul 20206 yr | |
| Aab (China) Co.,LtdHong Nanjie , Quanzhoushi, Fujiansheng CHINA | China | 7 Jul 20206 yr | |
| CTT Co., LtdBuilding 2 Of Industril Park No 197 Xinhua Blvd, Tongqiao Town,Zhongkai High-Tech Zone , Huizhou, Guangdong CHINA | China | 7 Jul 20206 yr | |
| Chuzhou Qiao Dong Industrial Co, LtdNo 259 Shanghai North Road , Chuzhou, Anhui CHINA | China | 7 Jul 20206 yr | |
| DADDYBABY CO.,LTDNo. 308 Suan Lingcun , Xincuozhen Fuqing , Fuzhou, Fujian CHINA | China | 7 Jul 20206 yr | |
| DONG GUAN KING YEAR PAPER PRODUCNO. 30 Longhua Rd, Went , District, Dongguan. , Dongguan, CHINA | China | 16 Jul 20206 yr | |
| DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD.Jinhe Road , No 78 Changping Jinmeicun; Changping Town , Dongguan, Guangdong CHINA | China | 7 Jul 20206 yr | |
| DONGGUAN LEIHUO MEDICAL DEVICE CO LTDDongshan Yongshenglu No. Room 47 , 101 Qishi; Dongshan Yongsheglu No , Dongguan, Guangdong CHINA | China | 7 Jul 20206 yr | |
| DONGGUAN XIANDA MEDICAL EQUIPMENT CO LTDBubugaogaofu Lou 7 Room 301 , No. 40 Longyan Road , Dongguan, Guangdong CHINA | China | 7 Jul 20206 yr | |
| FOSHAN NANHAI WEIJIAN SAN BANG PROTECTIVE PRODUCTS TECHNOLOGNanhai District , No. 5 Workshop,No.19 Yongxing North Street,Liansha Shadun Hu Village Development Zone; Danzao Town , F | China | 29 Jul 20206 yr | |
| GUANGDONG FEI FAN MSTAR TECHNOLOGY LTDA1 Workshop, No.10, Dongnan Xincun Avenue , Zone 2, Caobian No.3 Industrial Zone, Dali; Town Nanhai District , Foshan Ci | China | 29 Jul 20206 yr | |
| GUANGDONG KAPER PROTECTION TECHNOLOGY CO., LTDNo. 115 Xinghua Street , Dongfeng Town , Zhongshan, Guangdong CHINA | China | 13 Jul 20206 yr | |
| GUANGDONG NAFEI INDUST HOLDING4th Rd Ecological Tech , Guangdong, CHINA | China | 7 Jul 20206 yr | |
| GUANGDONG QIAN JING TESTING CO., LTD.Floor 2, building B and floor 3, building D, No. 30, Development Zone, Liusha, Puning City , Jieyang, Guangdong CHINA | China | 7 Jul 20206 yr | |
| GUANGZHOU AIYINMEI CO LTDTieshanhe Road , F/2; No. 18-21 San Dong Avenue; Xinhuazhen Huadou , Guangzhou, Guangdong CHINA | China | 31 Jul 20206 yr | |
| GUANGZHOU SUNJOY AUTO SUPPLIES CO., LTD.Xixian Industrial Zone,Kengtou, Nancun Town , Panyu District , Gaunzhou, Gaungdong, Guangdong CHINA | China | 7 Jul 20206 yr | |
| GUIZHOU BOCAI MEDICAL DEVICES CO LTDMedical And Health Industrial Park , Honghuagang , Zunyi, Guizhou CHINA | China | 31 Jul 20206 yr | |
| Guangdong For You Essentials Manufacturing Co., LtdNo. 6 Shanhua Road,Yanghe Towm , Gaoming District , Foshan, Guangdong CHINA | China | 7 Jul 20206 yr | |
| HONGRITA PRECISION COMPONENT ZHONo. 26 Zhongzhun Road, C , Zhongshan, CHINA | China | 22 Jun 20215 yr | |
| Huizhou Jiahe Cube Technology Co., LtdShiziling (Plant), Chenjiang Street Office , Zhongkai Avenue; Chenjiangzhen Huicheng , Huizhou, Guangdong CHINA | China | 29 Jul 20206 yr | |
| IMPROVE MEDICAL (HUNAN) CO., LTD.No. 6 Yizhang East Avenue, Economic Development , District, 424200 Yizhang , Chenzhou, Hunan CHINA | China | 31 Jul 20206 yr | |
| JIANGSU WEICHUANGLI NEW MATERIALS CO., LTD.Jute Technology Center , Shanghu; Town, Changshu , Suzhou, Jiangsu CHINA | China | 31 Jul 20206 yr | |
| JIANGXI HORNET INDUSTRIAL COMPANY LIMITEDShuidong Industrial Park Ningdu County , Ganzhou, Jiangxi CHINA | China | 7 Jul 20206 yr | |
| MEDICAL DEVICE BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL CO.,LTOf Building 4th Floor # 7 , No. 228 Jiaosong Road; Taiwanese Investment Zone , Zhangzhou, Fujian CHINA | China | 30 Jul 20206 yr | |
| MINGJIANG MEDICAL SUPPLIES CO LTDBuilding 63 201 , Longgang District; Pinghu Town Fumin Industrial Area , Shenzhen, Guangdong CHINA | China | 7 Jul 20206 yr | |
| NINGBO YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY CO., LTDNo. 26 Shangqiao Road, Xiwu Science Park, Fenghua , Ningbo, Zhejiang CHINA | China | 7 Jul 20206 yr | |
| QINGDAO ORPHILA MEDICAL TECHNOLOGY Co LimitedFutai Square Room , No. 18 Hongkong Middle Road , Qingdao, Shandong CHINA | China | 4 Aug 20206 yr | |
| SHANDONG DADDY'S CHOICE HEALTH SCIENCE AND TECHNOLOGY CO LTDIandingfeng Road Garden Street Economic , Development Zone Linyi County , Dezhou, Shandong CHINA | China | 31 Jul 20206 yr | |
| TIANJIN BENMO MEDICAL EQUIPMENT CO., LTD.D2-B1,Xuefu Industrial Zone West, No. 2 Xuefu Road,Xiqing District , Tianjin, Tianjin CHINA | China | 31 Jul 20206 yr | |
| YIWU HENGHAO HOUSEHOLD PRODUCTS CO.,LTDSecond Floor , No 18 Wenhua Road; Chianzhen Yiwu , Jinhua, Zhejiang CHINA | China | 7 Jul 20206 yr | |
| ZHEJIANG BAIYI INTELLIGENT GARMENT CO LTDFengshan 1 Road Industrial Park , No. 1 Hangbu Town; Kecheng , Quzhou, Zhejiang CHINA | China | 7 Jul 20206 yr | |
| ZHEJIANG SHENGTAI BABY PRODUCTS Co LtdNo. 379 Dongkang Road , Dongyang, Zhejiang CHINA | China | 31 Jul 20206 yr | |
| ZHENGZHOU WANSHENSHAN HEALTHCARE PPE CO., LTD.Xinmi City , Group 8, Miaozhu Village, Quliang Town , Zhengzhou, Henan CHINA | China | 7 Jul 20206 yr |