ARCHIVED 3. List of Medical Devices for Exceptional Importation and Sale [2020-05-21]
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: 2020-05-19
Date issued: 2020-05-20
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 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 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 |
| 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 |
| 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 |
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