FDA import alert

Import Alert 80-04

Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves

300

Red-list entries

Green-list entries

Countries

2025-04-21

Last change seen

Official FDA source ↗Data refreshed 2026-07-11 UTC

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.

Red-list entries by country

Country	Entries
China	149
Malaysia	41
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 30 of 300 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
ANHUI YINGSHUN MEDICAL PRODUCTS CO., LTD.
07/26/2024
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
Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD
08/01/2022
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China Jiangsu Medicines & Health Products Import
09/16/2009
China · Glove, Patient Examination; Glove, Patient Examination, Latex; Glove, Patient Examination, Vinyl
China Meheco Qingdao Import & Export Corp
09/16/2009
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
Evergreen Medical Products (Jiangxing) Co., Ltd.
09/16/2009
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
Fujian Ming Seng Ind Gloves (aka Sanming Foreign Trade Corp)
09/16/2009
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
HUBEI PROVINCIAL MEDICINES & HEALTH PRODUCTS I/E CORPORATION
04/23/2010
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

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