ARCHIVED 3. List of Medical Devices for Exceptional Importation and Sale [2020-05-19]

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: 2020-05-15
Date issued: 2020-05-19

Access archived versions of this list.

List of Medical Devices for Exceptional Importation and Sale

designated medical devices
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 11794 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 12183 2020-04-27
Surgical Face Mask I China Shandong Succare Medical Co. Ltd MDEL 9737 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
Face mask I China Rizhao Sangi Medical & Health Articles Co., Ltd MDEL 11908 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 SHIJIAZHUANG HONGRAY GROUP CO., LTD MDEL12167 2020-05-01
Sleeve I China SHIJIAZHUANG HONGRAY GROUP CO., LTD MDEL12167 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 1817 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
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