FDA import alert
Import Alert 80-04
Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves
301
Red-list entries
0
Green-list entries
16
Countries
2026-07-16
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
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Red-list entries by country
| Country | Entries |
|---|---|
| China | 149 |
| Malaysia | 42 |
| Taiwan | 24 |
| Thailand | 23 |
| Indonesia | 18 |
| India | 17 |
| Hong Kong SAR | 15 |
| Canada | 3 |
| Mexico | 3 |
| Colombia | 1 |
| Denmark | 1 |
| Korea (The Republic Of) | 1 |
| Philippines | 1 |
| Singapore | 1 |
| Sri Lanka | 1 |
| United Kingdom | 1 |
Firms on this red list
Showing 100 of 301 entries — search a specific firm on the free checker.
- Hedy Canada
09/16/2009
Canada · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- SUPERIOR GLOVE WORKS, LTD.
07/06/2012
Canada · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- W W Medicalsupplies
09/16/2009
Canada · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- ANHUI BYTECH MEDICAL SUPPLIES CO LTD
03/03/2025
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- ANHUI YINGTE MEDICAL PRODUCTS CO., LTD.
04/21/2025
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Advanced Medical Devices Factory
01/15/2014
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Aide Plastic Co., Ltd
09/20/2016
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Anhui Import & Export Corporation
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Baoding Guanzhong Glove Co., Ltd.
06/28/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- CHANGDA PLASTIC PRODUCT CO LTD
07/31/2012
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Chain Medical Products Co., Ltd.
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Changzhou Foreign Trade Corporation
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- DONGTAI CITY HUAYI GLOVES CO., LTD.
02/22/2024
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Dalian Anbao Latex Factory
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Decent Plastic Co Ltd
06/11/2014
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- E-Full Industrial Ltd.
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- FILTA SAFETY PRODUCTS CO LIMITED
10/25/2023
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Guangdong Kingfa Sci. & Tech. Co., Ltd.
01/03/2024
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Guilin Zizhu Latex Co., Ltd
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- HEBEI TENDA PLASTIC CO LTD
08/18/2012
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- HEZE JU XIN YUAN FOOD
04/05/2016
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- HUAGUANG MEDICAL PRODUCTS CO.,LTD.
11/08/2023
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Hebei Excellent Plastic Co Ltd
06/22/2011
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Hebei Favor Plastic Co., Ltd
08/28/2013
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Hebei Leader Plastic Co., Ltd.
08/08/2016
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Hebei Manful Inport & Export Co., Ltd.
06/02/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Hope Plastic Co., Ltd
06/09/2014
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Ideal Medical Industries
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- JIANGSU ALFA GLOVE CO LTD
05/04/2018
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Jewel Plastic Co. Ltd.
06/21/2017
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Jiangsu Jaysun Glove Co Ltd
01/02/2019
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Jiayuan Medical Products Co., Ltd.
11/16/2023
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- KAIXING PLASTIC PRODUCTS CO., LTD
10/02/2018
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- LPL (HUI ZHOU) GLOVE CO., LTD.
07/13/2016
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Letcom Medical Products Co.,Ltd.
10/12/2023
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Made Plastic Co. Ltd.
12/21/2018
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Medi Glove Co.,Ltd.
12/11/2024
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- NACROUS PLASTIC CO LTD
12/08/2016
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- NINGBO UNIMED MEDICAL INSTRUMENTCO LTD
06/02/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Nantong Ruchang Latex Products Co., Ltd.
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- PINNACLE CO., LTD
11/27/2023
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- QUANTUM CO., LTD.
02/14/2014
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Rayen Safety Products Limited
09/10/2012
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Rongyao Plastic Produce Co., Ltd
04/01/2019
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- SHIJIAZHUANG BENESTAR PLASTIC CO., LTD
07/23/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- SHIJIAZHUANG CENTURY PLASTIC CO., LTD.
08/16/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- SHIJIAZHUANG GLORY PLASTIC CO LTD
10/19/2016
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- SHIJIAZHUANG JIUYUAN PLASTIC CO., LTD
04/26/2018
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- SHIJIAZHUANG JIUYUAN PLASTIC CO., LTD
09/21/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD
10/08/2013
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- SHIJIAZHUANG WONDER PLASTIC CO., LTD.
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- SHUN TONG CO. LTD.
05/28/2013
China · Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shangdong Medicines Health Prod
04/23/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shanghai Changzheng Latex Factory
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shanghai ChinaStar Corporation
06/02/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shanghai Lanfan Co Ltd
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shanghai Poseidon Plastic Product Co Ltd
07/19/2011
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shanghai Strong Plastic Products Co Ltd
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shanghai Walnut Latex Products Co., Ltd
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shanghai-Foxboro Co., Ltd.
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shijiazhuang Brethern Plastic Co.,Ltd
04/20/2011
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shijiazhuang Holy Plastics Co., Ltd.
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shijiazhuang Hyland Plastic Co.Ltd.
08/19/2014
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shijiazhuang Sail Plastic Co Ltd
12/17/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shijiazhuang Star Plastic Co., Ltd
11/08/2010
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shijiazhuang Wally Plastic Co., Ltd.
03/12/2019
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Shijiazhuang Winful Plastic Co., Ltd.
08/01/2014
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Sinochem Hebei Imp/Exp Corp
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Suqian Green Glove Co Ltd
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Surefine Ningbo Medcare Co Ltd
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Suzhou Hengliang Imp.&Exp. Co., Ltd
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- Syntex Healthcare Products Co., Ltd.
02/13/2024
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- TANGSHAN HENGDA PLASTIC PRODUCTS CO LTD
09/28/2017
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- TANGSHAN HONGDA PLASTIC PRODUCTS
05/30/2023
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
- TANGSHAN JITENG PLASTIC PRODUCTS CO LTD
12/27/2011
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
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