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.

List of Medical Devices for Exceptional Importation and Sale
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.
IOB Medical Inc.

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
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