ARCHIVED 3. List of Medical Devices for Exceptional Importation and Sale [2020-07-08]
Notice to Reader:
This is an archived list. Please refer to the most current version of this list.
Medical devices included on this list are called "designated medical devices" and are eligible for the exceptional importation and sale provisions provided for in the Interim Order.
Supersedes: 2020-06-24
Date issued: 2020-07-03
Access archived versions of this list.
| Medical Device | Medical Device Category | Country of Manufacture | Name of Manufacturer | MDEL/MDL number | Date |
|---|---|---|---|---|---|
| Non-Woven Face Masks | I | China | Shenzhen Delong Huale Electronic Co. Ltd | MDEL 2332 | 2020-04-10 |
| Non-Woven Face Masks | I | China | Xiantao Xingrong Protective Products Co., Ltd. | MDEL 2332 | 2020-04-10 |
| Face Mask for Single Use | I | China | Wuxi Yushou Medical Appliances Co., Ltd. | MDEL 11700 | 2020-04-10 |
| N95 Respirators | I | China | Suzhou Fangtian Industries Co., Ltd. | MDEL 11700 | 2020-04-11 |
| N95 Respirators | I | China | Makrite Industries Inc. | MDEL 11700 | 2020-04-11 |
| Medical Grade Face Masks | I | China | V&Q Manufacturing Corporation | MDEL 9174 | 2020-04-17 |
| Isolation Gowns | I | China | Wuhan Orient Honest International Trade Co., Ltd | MDEL11707 | 2020-04-17 |
| Face Mask 3-Ply with Ear Loop / Tie | I | China | Shandong Zhushi Pharmaceutical Group Co., Ltd. | MDEL 6151 | 2020-04-17 |
| Surgical Masks | I | China | Xiantao Xingrong Protective Products Co., Ltd. | MDEL 6732 | 2020-04-17 |
| 3-Ply Face Masks, with Earloops | I | China | Hubei Fullcare Protective Products Co., Ltd. | MDEL 1841 | 2020-04-17 |
| Newport HT-50 Ventilator | III | USA | Newport Medical Instruments Inc. | MDEL 11862 | 2020-04-17 |
| Face Masks | I | China | Guangdong Owgels Science & Technology Co., Ltd. | MDEL 11754 | 2020-04-22 |
| Surgical Masks | I | China | GFA Production Xiamen Co., Ltd. | MDEL 2857 | 2020-04-22 |
| Masks | I | China | Gaozhou Taiming Protective Equipment Co., Ltd. | MDEL 11929 | 2020-04-22 |
| Masks | I | China | Shandong Zhushi Pharmaceutical Group Co., Ltd | MDEL 11908 | 2020-04-22 |
| Non-Sterile Face Masks | I | China | Shenzhen Senton Medical Device Co., Ltd. | MDEL 1071 | 2020-04-22 |
| Surgical Masks | I | China | Henan Tuoren Sanrui Medical Devices Co., Ltd. | MDEL 12133 | 2020-04-22 |
| Surgical Masks | I | China | Jiangxi Longteng Biological High-tech Co., Ltd | MDEL 11791 | 2020-04-22 |
| Masks | I | China | Peek-a-Boo! I A See U! | MDEL 11790 | 2020-04-24 |
| Examination gloves | II | Malaysia | Hartalega NGC Sdn Bhd | MDEL 38 | 2020-04-24 |
| 3 Ply Ear-loop Disposable Facemask | I | China | Bejing Hanbaihan Medical Devices Co., Ltd. | MDEL 7575 | 2020-04-27 |
| Gowns | I | China | Zhejiang Meiyi Clothing Technology Company | MDEL 11656 | 2020-04-27 |
| Medical Face Shield | I | China | Andent Dental Co. Ltd (China) | MDEL 9737 | 2020-04-27 |
| Surgical Face Mask | I | China | Shandong Succare Medical Co. Ltd | MDEL 12183 | 2020-04-27 |
| Disposable Medical Face Mask | I | China | Shandong Zhushi Pharmaceuticals Group Co. Ltd. | MDEL 1841 | 2020-05-01 |
| Disposable Face Mask | I | China | Henan Liwei Biological Pharmaceutical Co., Ltd. | MDEL 11777 | 2020-05-01 |
| Disposable Face Mask | I | China | Nanchang Zhenfeng Medical Equipment Co., Limited | MDEL 12243 | 2020-05-01 |
| Medical Protective Suits | I | China | Kunshan Jiehong nonwoven products Co., Ltd | MDEL 9917 | 2020-05-01 |
| Surgical Face mask with ear loop | I | China | Showing Polymer Limited | MDEL 1545 | 2020-05-01 |
| Isolation Gown | I | China | Wuhan Orient Honest International Trade Co., Ltd | MDEL 11707 | 2020-05-01 |
| Disposable Face Mask | I | China | Wuhan Orient Honest International Trade Co., Ltd | MDEL 11707 | 2020-05-01 |
| Medical Disposable Mask | I | China | Hunan Bei'er An'qin Medical Technology Co., Ltd | MDEL 11791 | 2020-05-01 |
| Isolation Gown | I | China | Showing Polymer Limited | MDEL11721 | 2020-05-01 |
| Apron | I | China | Showing Polymer Limited | MDEL11721 | 2020-05-01 |
| Sleeve | I | China | Showing Polymer Limited | MDEL11721 | 2020-05-01 |
| Surgical Gowns | I | USA | Cardinal Health | MDEL 203 | 2020-05-12 |
| Medical Face Mask (3-ply) | I | China | Taizhou Rich Medical Products Co, Ltd. | MDEL 9174 | 2020-05-12 |
| Cardinal Health Gowns | I | USA | Cardinal Health | MDEL 203 | 2020-05-12 |
| Non Sterile Face Mask | I | USA | Future Generations Medical | MDEL 203 | 2020-05-12 |
| Surgical Face Mask with ear loops | I | Malaysia | Cross Protection (M) SDN BHD | MDEL 5558 | 2020-05-12 |
| 3-Ply Surgical Mask with Ear Loops | I | China | Xingrong Protective Products Co., Ltd | MDEL 12236 | 2020-05-12 |
| 3-Ply Surgical Mask with Ear Loops | I | China | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | MDEL 2332 | 2020-05-12 |
| 3-Ply Surgical Mask with Ear Loops | I | China | Fujian Leephick Pharmaceutical Industry Co. Ltd. | MDEL 11767 | 2020-05-12 |
| Protective Face Mask | I | China | Shenzhen Senton Medical Device Co., Ltd. | MDEL 1071 | 2020-05-12 |
| Top Glove Latex Medical Examination Gloves | II | Malaysia | TG Medical Sdn. Bhd. | MDEL 1602 | 2020-05-12 |
| Top Glove Nitrile Examination Gloves | II | Malaysia | TG Medical Sdn. Bhd. | MDEL 1602 | 2020-05-12 |
| Face Mask 3ply with Earloop/Tie | I | China | Shandong Zhushi Pharmaceutical Group Co., Ltd | MDEL 11908 | 2020-05-12 |
| Disposable 3-ply Surgical Mask | I | China | Henan Tuoren Medical Device Co., Ltd. | MDEL 11978 | 2020-05-12 |
| Disposible Hooded Coveralls (Tyvek 500 Xpert, Tyvek 600 Plus) | I | China | DuPont de Nemours (Luxembourg) S.ar.l. C/O Du Pont China Holding Co., Ltd. | MDEL 11978 | 2020-05-12 |
| Disposable face mask with ear loops | I | China | Guangdong Hygeia Medical Devices Manufacturing Co., Ltd. | MDEL 11978 | 2020-05-12 |
| 3-Ply Face Mask | I | China | Nanjing FoinNoe Co ltd | MDEL 3202 | 2020-05-15 |
| Medical Disposable Protective Suit/Isolation Gown | I | China | Shandong Zhushi Pharmaceutical Group Co., Ltd | MDEL 11978 | 2020-05-15 |
| Disposable isolation coveralls | I | China | Foshan Ruiniu Clothing Co. Ltd. | MDEL 1841 | 2020-05-15 |
| Disposable isolation coveralls | I | China | Yiwu Huabiao Packaging Co., Ltd. | MDEL 5123 | 2020-05-15 |
| 3-Ply Face Mask with Ear Loops | I | China | Hubei Fullcare Protective Products Co. Ltd. | MDEL 1841 | 2020-05-15 |
| Face Mask 3ply Earloop | I | China | Changzhou Leyi Medical Device Co., Ltd. | MDEL 2468 | 2020-05-15 |
| Disposable Medical Face Mask | I | China | Crown Name Disposable Hygiene Products Fty. Ltd. | MDEL 11684 | 2020-05-15 |
| Respiratory Filter | I | China | Bird Healthcare Pty Ltd | MDEL 4057 | 2020-05-15 |
| Non-Woven Isolation Gown | I | China | Zibo Minghui Logo Clothing Co., Ltd. | MDEL 12291 | 2020-05-15 |
| Disposable Face Mask | I | China | Hangzhou Yuhong Sanitary Products Co Ltd | MDEL 11787 | 2020-05-15 |
| N95 Particulate Respirator | I | China | Guangzhou Harley commodity company Ltd. | MDEL 0493 | 2020-05-15 |
| Medical Faceshield | I | China | BDC Dental Corporation Ltd. | MDEL 7371 | 2020-05-15 |
| Disposable Gown | I | China | Xiantao Tongda Non-Woven Products Co., Ltd. | MDEL 11822 | 2020-05-19 |
| Dynapro Earloop Procedure Masks | I | China | Hangzhou (Hilltop) Co. Ltd. | MDEL 9311 | 2020-05-20 |
| Disposable 3-ply non-woven medical face mask with ear loops | I | China | Hubei Qianjiang Kingphar Medical Material Co. Ltd. | MDEL 12291 | 2020-05-20 |
| Surgical Masks | I | China | Shandong Huien Medical Device Co., Ltd. | MDEL 11877 | 2020-05-21 |
| N95 Respirator | I | China | San Huei United Co., Ltd. | MDEL 11873 | 2020-06-01 |
| Nitrile examination Powder-free glove | II | China | TG Medical Sdn. Bhd. | MDEL 1602 | 2020-06-01 |
| Face Mask, Disposable Non-woven | I | China | Xiantao Daoqi Plastic Co., Ltd. | MDEL 12127 | 2020-06-01 |
| Face Mask, Disposable Non-woven | I | China | Changzhou Jiuhong Medical Instruments Company., Ltd. | MDEL 1817 | 2020-06-01 |
| Disposable medical Face Mask with ear loops (LKY-010-A Type I) | I | China | Qingdao Likangyuan Medical Device Co. Ltd. | MDEL 11873 | 2020-06-01 |
| Disposable surgical Face Mask with ear loops (LKY-023-A Type IIR) | I | China | Qingdao Likangyuan Medical Device Co. Ltd. | MDEL 11873 | 2020-06-01 |
| Disposable Surgical Face Mask with ear loops | I | China | Jiangsu Eyoung Medical Devices Co. Ltd | MDEL 11920 | 2020-06-01 |
| Disposable Medical Surgical Face Mask with ear loops | I | China | Jiangxi Hongda Medical Equipment Group Ltd. | MDEL 11765 | 2020-06-01 |
| Disposable Isolation Gowns | I | China | G-Top Garments Co. Ltd. | MDEL 12294 | 2020-06-01 |
| Single-use medical face mask | I | China | Henan Siyuan Medical Equipment Co. Ltd. | MDEL 10177 | 2020-06-01 |
| Disposable Medical Face Mask | I | China | Topmedi Company Ltd. | MDEL 10178 | 2020-06-01 |
| N95 Particulate Respirator | I | China | Guangzhou Harley Commodity Co., Ltd. | MDEL 11873 | 2020-06-01 |
| Medical face shield | I | China | Guilin Woodpecker Medical Instrument Co. Ltd. | MDEL 7169 | 2020-06-01 |
| Medical goggles | I | China | Guilin Woodpecker Medical Instrument Co. Ltd. | MDEL 7169 | 2020-06-01 |
| Disposable Medical Face Mask | I | China | Sunsmed Protective Products Ltd | MDEL 726 | 2020-06-01 |
| Face Shield | I | Canada | 3D4MD Inc. | MDEL 8946 | 2020-06-01 |
| Nitrile medical gloves | II | Malaysia | UG Global Resources SDN BHD | MDEL 654 | 2020-06-01 |
| Disposable Medical Mask | I | China | Hubei Weikang Protective Products Co. Ltd. | MDEL 11988 | 2020-06-01 |
| Face Mask, 3-ply disposable | I | China | Hubei Fullcare Protective Products Co., Ltd. | MDEL 11791 | 2020-06-01 |
| Disposable Surgical Face Mask non-woven with ear loops | I | China | Henan Tuoren Best Medical Device Co., Ltd | MDEL 12236 | 2020-06-01 |
| Disposable 3-ply Medical Face Mask with ear loops | I | China | Zhengzhou Wanshenshan Healthcare PPE Co., Ltd | MDEL 5901 | 2020-06-02 |
| SafeMask Procedure Earloop Face Mask | I | USA | United Medical Enterprises | MDEL 0654 | 2020-06-02 |
| Disposable Medical Face Mask with Ear Loops | I | China | Jiangsu Eyoung Medical Devices Co., Ltd | MDEL 11765 | 2020-06-02 |
| Fluid Resistant 4-ply Procedure Mask | I | Vietnam | Lam Khang General Joint Stock Company | MDEL 6279 | 2020-06-02 |
| Disposable Face Mask | I | Hong Kong | Win Concept Enterprises Ltd. | MDEL 13049 | 2020-06-04 |
| Disposable Face Mask with Ear Loops | I | China | BDC Dental Corporation Ltd. | MDEL 7371 | 2020-06-04 |
| Disposable 3-Ply Medical Face Mask with Ear Loops | I | China | Esound Medical Device Co., Ltd. | MDEL 11873 | 2020-06-04 |
| Single-use Medical Face Mask with Ear Loops | I | China | Hunan Sanrui Biotechnology Co., Ltd. | MDEL 11860 | 2020-06-04 |
| Disposable Emergency Medical Garment | I | China | Hunan Yourfield Special Proctive Equipment Co., Ltd. | MDEL 11860 | 2020-06-04 |
| Medical Safety Goggles | I | China | Ourlook (Zhangzhou) Optical Technology Co., Ltd. | MDEL 11860 | 2020-06-04 |
| Single-use Medical Face Mask | I | China | Henan Siyuan Medical Equipment Co. Ltd. | MDEL 10177 | 2020-06-04 |
| Disposable 3-ply Face Mask with ear loops | I | China | Guangdong Taibao Medical Science and Technology Co., Ltd. | MDEL 11824 | 2020-06-04 |
| Disposable Face Mask | I | China | Nantong Gold-Sufang Weaving Co. Ltd. | MDEL 2468 | 2020-06-04 |
| Disposable Face Mask | I | China | Guangzhou DEYCE Leather Co., Ltd. | MDEL 2468 | 2020-06-04 |
| Disposable Face Mask | I | China | Fujian Yingdawo Medical Technology Co., Ltd. | MDEL 2468 | 2020-06-04 |
| 4 Layers Medical Face Mask | I | Vietnam | Nam Finance Group Joint Stock Company | MDEL 13485 | 2020-06-17 |
| Disposable Mask | I | China | Zhejiang QianXiang Technology Co.,Ltd | MDEL 13029 | 2020-06-17 |
| Disposable Surgical mask | I | China | ChangZhou Shuangma Medical Devices Co., Ltd | MDEL 11684 | 2020-06-17 |
| 3-ply Non-Woven Medical Face Mask With Ear Loops | I | China | Suzhou Dongshan Precision Manufacturing Co., Ltd. | MDEL 12745 | 2020-06-17 |
| Bio Base Single-Use Medical Face Mask | I | China | Biobase | MDEL 11921 | 2020-06-17 |
| Isolation gowns | I | China | Liaoning Yimao Garment Co., Ltd | MDEL 5901 | 2020-06-17 |
| Disposable Face Mask, 3ply with earloop | I | China | Richfield Dynamic Technology Ltd. | MDEL 13137 | 2020-06-17 |
| Single-use Medical Face Mask | I | China | Duoling Clean air Technology Co., Ltd | MDEL 11878 | 2020-06-17 |
| Disposable Mask, Non-Sterile | I | China | Zhongshan Jimei Cosmetics Co., LTD | MDEL 13088 | 2020-06-17 |
| Disposable Face Masks | I | China | Xiamen Teshi Technology Co., Ltd. | MDEL 13404 | 2020-06-17 |
| Disposable Isolation Medical Clothing Coveralls with Hood | I | China | CHENGDU ORIENTAL HEALTH INDUSTRY CO., LTD | MDEL 13544 | 2020-06-17 |
| Disposable Isolation Medical Clothing Non-Surgical Isolation Gown | I | China | CHENGDU ORIENTAL HEALTH INDUSTRY CO., LTD | MDEL 13544 | 2020-06-17 |
| Tenamyd 4ply Medical Face Mask | I | Vietnam | TENAMYD PHARMACEUTICAL CORPORATION | MDEL 13475 | 2020-06-17 |
| Visi-Guard Face Shield | I | Canada | Percept Systems Inc. | MDEL 11981 | 2020-06-17 |
| Inspiration Gown | I | USA | Fairfield Processing Corporation | MDEL 3982 | 2020-06-17 |
| Disposable Surgical Mask | I | China | Tianjin Just Truth Advanced Material Technology Co.,Ltd. | MDEL 11626 | 2020-06-17 |
| Disposable Medical Mask | I | China | HUBEI WEIKANG PROTECTIVE PRODUCTS CO., LTD | MDEL 11791 | 2020-06-17 |
| Single-Use Medical Face Mask | I | China | Xiamen Chuanfutang Pharmaceutical Co. Ltd | MDEL 493 | 2020-06-17 |
| Disposable Mask | I | China | Gansu Newshanyou Medical Instruments Co. Ltd. | MDEL 11767 | 2020-06-17 |
| Disposable Face Shield | I | USA | Custom Comfort Medtek LLC | MDEL 9476 | 2020-06-17 |
| Face Mask, 3ply with earloops | I | China | Fuyang Xinyuan Medical Products Co., Ltd. | MDEL 12301 | 2020-06-17 |
| Disposable Face Mask | I | China | Zhejiang Stage Leather Apparel Co., Ltd. | MDEL 12301 | 2020-06-17 |
| Disposable face mask with ear loops | I | China | BM Medical Technology Co., Ltd. | MDEL 11610 | 2020-06-17 |
| Disposable Protective Mask | I | Vietnam | Thanh Tam Medical Equipment Company Limited | MDEL 13411 | 2020-06-17 |
| Disposable Medical Mask | I | China | Guangzhou Sunrise Sanitary Articles Co., Ltd | MDEL 13137 | 2020-06-17 |
| 3ply Disposable Face Mask | I | China | Jianyi Enterprises |
MDEL 11891 | 2020-06-24 |
| Face Mask with Earloops | I | China | Hubei Safeway Protective Products Co. Ltd. | MDEL 203 | 2020-06-24 |
| KN95 Disposable Respirator | I | China | Zhuhai IVI Medical Device Co., Ltd. |
MDEL 11716 | 2020-06-24 |
| N95 Particulate Respirators 9500-N95 | I | China | Makrite Industry Inc |
MDEL 11593 | 2020-06-24 |
| FFP2 Ear Face Mask | I | China | Zhongshan Dongfeng Huanshang Electronics Factory | MDEL 4617 | 2020-06-24 |
| Surgical Mask | I | China | Shaanxi Hongji Pharmaceutical Co., Ltd | MDEL 12323 | 2020-07-03 |
| Disposable Medical Mask | I | China | Shaanxi Hongji Pharmaceutical Co., Ltd | MDEL 12323 | 2020-07-03 |
| Medical Mask | I | China | Zhende Medical Co. Ltd. | MDEL 12350 | 2020-07-03 |
| Disposable Face Mask | I | China | Shandong Shengquan New Materials Co. Ltd. | MDEL 14022 | 2020-07-03 |
| Disposable Medical 3-ply Non-Woven Face Mask | I | Taiwan | Sum Easy Enterprise Co. Ltd. | MDEL 13878 | 2020-07-03 |
| Single-Use Medical Face Mask | I | China | Henan Siyuan Medical Equipment Co., Ltd | MDEL 14137 | 2020-07-03 |
| Disposable Isolation Gowns | I | China | Beijing ZKSK Technology Co. Ltd. | MDEL 13035 | 2020-07-03 |
| Disposable Medical Face Mask | I | China | Xiantao Daoqi Plastic Co. Ltd. | MDEL 13035 | 2020-07-03 |
Page details
- Date modified: