Data / Medical devices / Respirator, Surgical

Respirator, Surgical (MSH): 159 FDA-registered makers in 15 countries

Name: FDA-registered makers of Respirator, Surgical
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

159 establishments in 15 countries are registered with the FDA to make Respirator, Surgical (product code MSH, Class 2, 21 CFR 878.4040). 25 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on January 12, 2024, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: MSH
Device class: 2
Regulation: 878.4040
Medical specialty: General, Plastic Surgery

Makers by country

Country	Makers
China	103
United States	25
South Korea	8
Vietnam	4
Canada	3
India	3
Mexico	2
Taiwan	2
Thailand	2
Japan	2
Sweden	1
Singapore	1
Hong Kong	1
Colombia	1
Australia	1

Makers of Respirator, Surgical

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Moldex/Metric, Inc.	Culver City, CA, United States	Manufacturer	4	September 13, 2010	2	api.fda.gov
3M Company	Saint Paul, MN, United States	Complaint file establishment, Specification developer	2	August 10, 2017	0	api.fda.gov
3M Company	Aberdeen, SD, United States	Manufacturer	2	August 10, 2017	0	api.fda.gov
La Ada de Acuna	CIUDAD DE ACUNA Coahuila, Mexico	Manufacturer	2	January 12, 2024	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Complaint file establishment, Specification developer	2	October 21, 2009	0	api.fda.gov
O&M Halyard, Inc.	Alpharetta, GA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	2	January 12, 2024	0	api.fda.gov
O&M Halyard, Inc. (La Ada de Acuna)	Del Rio, TX, United States	Manufacturer	2	January 12, 2024	0	api.fda.gov
Aero Pro Co., Ltd.	CHANG HUA HSIEN Changhua, Taiwan	Exporter to the US, Manufacturer	1	January 8, 2008	0	api.fda.gov
Alphaprotech, Inc.	Nogales, AZ, United States	Manufacturer	1	October 21, 2009	0	api.fda.gov
AMD Medicom Inc.	Pointe-Claire, Montreal Quebec, Canada	Complaint file establishment, Exporter to the US, Specification developer	1	July 23, 2002	0	api.fda.gov
Ansell Healthcare Products LLC	Reno, NV, United States	Manufacturer, Specification developer	1	May 4, 2010	0	api.fda.gov
Apothecary Products, LLC.	Burnsville, MN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	1	July 23, 2002	0	api.fda.gov
Arrow Medsource Group Limited	Hongkong, China	Exporter to the US, Specification developer	1	July 23, 2002	0	api.fda.gov
Dongguan Shin Yi Healthcare Products Factory	DONG GUAN CITY Guangdong, China	Manufacturer	1	April 4, 2018	0	api.fda.gov
Dongguan Sure On Plastic and Fiber Product Co., Ltd.	DONG GUAN CITY Guangdong, China	Manufacturer	1	July 23, 2002	0	api.fda.gov
Hydrochem Co., Ltd	Gangeung-Si Gangwon, South Korea	Manufacturer	1	January 12, 2024	0	api.fda.gov
Kbbio Co., Ltd.	Seongnam Gyeonggi, South Korea	Manufacturer	1	January 12, 2024	0	api.fda.gov
Louis M. Gerson Co., Inc.	Middleboro, MA, United States	Manufacturer	1	November 17, 2006	0	api.fda.gov
Makrite Hubei Industrial Co., Ltd.	Chibi High-Tech Zone Hubei, China	Manufacturer	1	July 23, 2002	0	api.fda.gov
Makrite Industrial (Thailand) CO., LTD.	SI RACHA Chon Buri, Thailand	Manufacturer	1	July 23, 2002	0	api.fda.gov
Molnlycke Health Care AB	Molndal Vastra Gotaland, Sweden	Specification developer	1	November 19, 2010	0	api.fda.gov
Pasture Pharma Pte Ltd	Corporation Place Central Singapore, Singapore	Contract manufacturer, Exporter to the US, Manufacturer	1	October 28, 2015	0	api.fda.gov
Prestige Ameritech	North Richland Hills, TX, United States	Contract manufacturer, Manufacturer	1	October 6, 2010	0	api.fda.gov
San-M Package Co., Ltd.	Shimada-city Shizuoka, Japan	Manufacturer	1	July 15, 2016	0	api.fda.gov
Shanghai Gangkai Purifying Products Co., Ltd.	Songjiang Shanghai, China	Manufacturer	1	December 8, 2006	0	api.fda.gov
Aab (china) Co., Ltd.	Nanan City Fujian, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Advanced Concept Innovations LLC	Lakeland, FL, United States	Manufacturer	0		0	api.fda.gov
Amd Medicom Inc.	Saint-Laurent Quebec, Canada	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Anji Anshen Surgical Dressings Co., Ltd.	Huzhou, Zhejiang, China	Exporter to the US, Manufacturer, Specification developer	0		0	api.fda.gov
Anji Hengfeng Sanitary Material Co., Ltd.	Anji Zhejiang, China	Contract manufacturer, Foreign private label distributor, Manufacturer	0		0	api.fda.gov
AOK Tooling Limited	Shen Zhen Guangdong, China	Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Anqing Mayfield Medical Limited	Anqing Anhui, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Beijing ZKSK Technology Co., Ltd.	beijing, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Biobase Biodustry(shandong)co., Ltd	Jinan Shandong, China	Manufacturer	0		0	api.fda.gov
BK Medicare Co., Ltd.	Yangsan Gyeongnam, South Korea	Manufacturer	0		0	api.fda.gov
Blue Sail (hong Kong) Trading Limited	Harbour, Hong Kong	Exporter to the US, Specification developer	0		0	api.fda.gov
BNX Converting, LLC	Houston, TX, United States	Manufacturer	0		0	api.fda.gov
Bound Tree Medical, LLC	Grand Prairie, TX, United States	Manufacturer	0		0	api.fda.gov
Chamfond Biotech Co., Ltd.	Nanjing Jiangsu, China	Manufacturer	0		0	api.fda.gov
Changzhou Lookmed Medical Instrument Co.,ltd	Changzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Charmant, Inc.	Sabae-City, Fukui-Pref., Japan	Manufacturer	0		0	api.fda.gov
Chengde Technology Co., Ltd	Longgang Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Changzhou CareU Medical Instruments Co., Ltd.	Changzhou City Jiangsu, China	Manufacturer	0		0	api.fda.gov
Coomex Sources Co. Ltd.	Qingdao City Shandong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.	Shijiazhuang Hebei, China	Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Demetech Corp.	Miami Lakes, FL, United States	Manufacturer	0		0	api.fda.gov
Dongguan Luda Industrial Co., Ltd	Dongguan Guangdong, China	Manufacturer	0		0	api.fda.gov
Dongguan Sengtor Plastics Products Co., Ltd.	Dongguan Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Dongyang City Yonoel Outdoor Products Co.,ltd	Dongyang Zhejiang, China	Exporter to the US, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Dongguan Mars Medical Products Co., Ltd.	Dongguan City Guangdong, China	Manufacturer	0		0	api.fda.gov
Evergreen Co.,ltd	Gyeonggido, South Korea	Manufacturer	0		0	api.fda.gov
FIRSTAR HEALTHCARE Company Limited (Guangzhou)	Guangzhou Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Foshan Niceday Sanitary Products Co., Ltd.	Foshan Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Fujian Time And Tianhe Industrial Co., Ltd	Nanan Fujian, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Fujian Hui'an Hecheng Household Products Co., Ltd	Quanzhou Fujian, China	Manufacturer	0		0	api.fda.gov
Fujian JR Hygiene Products Company Limited	QUANZHOU Fujian, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Galia Textil S.A. De C.V.	Xiloxoxtla, Tlaxcala, Mexico	Contract sterilizer, Manufacturer	0		0	api.fda.gov
Guangdong Dexin Sports Industry Co.,ltd	Guangzhou Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Guangdong Ecan Medical Co,ltd	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Guangzhou Baoli Hardware & Electronic Co.,ltd.	Guangzhou Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Guangzhou Nanqixing Nonwoven Co., Ltd.	guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Hanghai Medical Products Co Ltd	Jinhua City Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Alline Plastic Co., Ltd.	HANGZHOU Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Coco Healthcare Products Co.,ltd.	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Shanyou Medical Equipment Co.,ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Shujie Hygiene Products Co., Ltd	Hangzhou City Zhejiang, China	Manufacturer	0		0	api.fda.gov
HANGZHOU TUOPUSI MEDICAL PRODUCTS Co. Ltd	Hangzhou City Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hanh Minh Manufacturing Trading Company Limited	Bien Hoa Dong Nai, Vietnam	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
HBH Biotechnology Limited	Yantai Shandong, China	Exporter to the US, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Healthplus, LLC	Asheville, NC, United States	Manufacturer	0		0	api.fda.gov
Henan Huibo Medical Co., Ltd	Nanyang City Henan, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Huaian Angel Medical Instrument Co., Ltd	Huaian Jiangsu, China	Manufacturer	0		0	api.fda.gov
Hubei Qifu Protective Products Co.,ltd	Xiantao Hubei, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hubei Wanli Protective Products Co.,ltd	xiantao Hubei, China	Manufacturer	0		0	api.fda.gov
Hubei Haixin Protective Products Group Co.,Ltd	Songzi City Hubei, China	Manufacturer	0		0	api.fda.gov
Jiangsu Hongxin Medical Technology Co, Ltd.	Shuyang City Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Jiangsu Liyu Razor Company Limited	SUQIAN Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Jiangsu Rongye Technology Co.,ltd	Yangzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangsu Yongle Medical Technology Co., Ltd.	Taixing City Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangxi 3L Medical Products Group Co., Ltd	Nanchang Jiangxi, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Jiangxi Aicare Medical Technology Co., Ltd	Fuzhou Jiangxi, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Jiangyin Everise Medical Equipment Co., Ltd.	Jiangyin Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Jiarui Invest Industry Co., Ltd.	Hsien Changhua, Taiwan	Manufacturer	0		0	api.fda.gov
Jiujiang Huada Medical Dressing Co., Ltd.	JIUJIANG Jiangxi, China	Manufacturer	0		0	api.fda.gov
Juntech (jiaxing) Healthcare Materials Co., Ltd.	Nanhu District, Jiaxing Zhejiang, China	Manufacturer	0		0	api.fda.gov
Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangsu Nanfang Medical Co., Ltd.	CHANGZHOU Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangyin Huashi Medical Equipment Co.,Ltd	Jiangyin City Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Kyungin Flax Co.,ltd	Ansan-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Laguna Scientific	Aliso Viejo, CA, United States	Specification developer	0		0	api.fda.gov
Lty Co., Ltd.	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
LTY Jeonju Factory Co., Ltd.	Wanju-gun Jeonbuk, South Korea	Manufacturer	0		0	api.fda.gov
LWS Health & Safety	White City, OR, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Magnum Health And Safety Pvt Ltd	TALUKA - VASAI PALGHAR Maharashtra, India	Manufacturer	0		0	api.fda.gov
Mark Enterprises	Nashik Maharashtra, India	Manufacturer	0		0	api.fda.gov
MB Regentox Vietnam Trading Service Company Limited	Ho Chi Minh City, Vietnam	Foreign private label distributor, Manufacturer	0		0	api.fda.gov
Medstar Healthcare Co.,limited	Huzhou Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Megasoft (china) Co.,ltd.	Shishi Fujian, China	Manufacturer	0		0	api.fda.gov
Mid-America Safety Corp	Elk Grove Village, IL, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Narang Medical, Ltd.	New Delhi, India	Manufacturer	0		0	api.fda.gov
Ningbo Chibanda Imp &exp Co, Ltd	Ningbo Zhejiang, China	Manufacturer	0		0	api.fda.gov
Nitta S.A.	Bogota, Colombia	Manufacturer	0		0	api.fda.gov
Obbomed Group LLC	Pomona, CA, United States	Specification developer	0		0	api.fda.gov
Orich Medical Equipment (tianjin) Co., Ltd.	Tianjin, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Ouachita Contract Manufacturing, LLC	Monroe, LA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Podo Xingda (tianjin) Medical Co., Ltd.	Tianjin, China	Manufacturer	0		0	api.fda.gov
Profit Royal Pharmaceutical Limited	Kowloon Hong Kong, China	Manufacturer	0		0	api.fda.gov
Picard Healthcare Technology (Dongguan) Co. Ltd	Dongguan Guangdong, China	Manufacturer	0		0	api.fda.gov
Principle & Will Biotech (Pinghu) Co., Ltd.	Pinghu City Zhejiang, China	Manufacturer	0		0	api.fda.gov
Qingdao Bestex Rubber & Plastic Products Co., Ltd	PINGDU, QINGDAO Shandong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Qinhuangdao Taizhi Medical Technology Co., Ltd	Qinhuangdao Hebei, China	Manufacturer	0		0	api.fda.gov
Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation	Dien Ban Bac Ward Da Nang, Vietnam	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Quanzhou Huifeng Sanitary Articles Co.,ltd	QUANZHOU Fujian, China	Manufacturer	0		0	api.fda.gov
Riskwise Supplies LLC	Lorton, VA, United States	Manufacturer	0		0	api.fda.gov
Rizhao Sanqi Medical & Health Articles Co., Ltd	Rizhao Shandong, China	Manufacturer	0		0	api.fda.gov
Secure Manufacturing (thailand) Co., Ltd.	Bangkok Krung Thep Maha Nakhon, Thailand	Contract manufacturer	0		0	api.fda.gov
Secure Personal Care Products, LLC	South San Francisco, CA, United States	Specification developer	0		0	api.fda.gov
Shaoxing Reborn Medical Devices Co.,ltd	Shaoxing Zhejiang, China	Manufacturer	0		0	api.fda.gov
Shenzhen Fittop Health Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Joose Beauty Electronic Co.,ltd	Shen Zhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer	0		0	api.fda.gov
Shenzhen Youmay Electronics Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shurcon Manufacturing Company	Jia Shan Zhejiang, China	Manufacturer	0		0	api.fda.gov
Splashblocker Distribution Company, LLC	Yardley, PA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Stevimed Medical Joint Stock Company	Can Giuoc Commune Tay Ninh, Vietnam	Manufacturer	0		0	api.fda.gov
Strapit Medical And Sports Supplies	Thomastown Victoria, Australia	Manufacturer	0		0	api.fda.gov
STS Corporation	Duluth, GA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Suzhou Emy Medical Supplies Co.,ltd.	ChangShu Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.	SUZHOU Jiangsu, China	Manufacturer	0		0	api.fda.gov
Suzhou Shangchuang Technology Service Co., Ltd.	Suzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Shanghai Care Us Medical Product Co., Ltd.	Shanghai, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Shanghai Joy Crown Industry Co., Ltd	Pu Dong New Area Shanghai, China	Contract manufacturer	0		0	api.fda.gov
Shenzhen reanson products co.,ltd.	SHENZHEN Guangdong, China	Manufacturer	0		0	api.fda.gov
Tia	Gimje-si Jeonbuk, South Korea	Manufacturer	0		0	api.fda.gov
Tylenol Medical Instruments Co., Ltd.	Zhongshan Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Vistar Medical Supplies Co., Ltd.	SHENZHEN Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Vitacore Industries	Port Coquitlam British Columbia, Canada	Manufacturer	0		0	api.fda.gov
Weihai Dishang Medical Technology Co.,ltd	Weihai Shandong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Wellpower Sporting Goods Co., Ltd.	Dong Guan Guangdong, China	Contract manufacturer	0		0	api.fda.gov
Wenzhou Dongfang Medical Instruments Co., Ltd	WENZHOU Zhejiang, China	Manufacturer	0		0	api.fda.gov
Weihai Hongyu Nonwoven Fabric Products Co.,Ltd	Weihai Shandong, China	Manufacturer	0		0	api.fda.gov
Xiamen Chengli Medical Equipment Co., Ltd.	Xiamen Fujian, China	Manufacturer	0		0	api.fda.gov
Xiamen Chuanfutang Pharmaceutical Co.,ltd	xiamen Fujian, China	Manufacturer	0		0	api.fda.gov
Xiamen Healthcare Electronic Co.,ltd.	Xiamen Fujian, China	Manufacturer	0		0	api.fda.gov
Xiamen J-Brace Medical Equipment Co., Ltd.	Xiamen Fujian, China	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Xiantao Xingrong Protective Products Co., Ltd.	Xiantao Hubei, China	Manufacturer	0		0	api.fda.gov
Xiantao Yunxiang Protective Products Co., Ltd	XIANTAO Hubei, China	Manufacturer	0		0	api.fda.gov
Xiantao Zhongyi Safety & Protection Products Co.,Ltd.	Xiantao City Hubei, China	Manufacturer	0		0	api.fda.gov
Yadu Medical (henan) Co., Ltd	Changyuan Henan, China	Manufacturer	0		0	api.fda.gov
Yangzhou Medline Industry Co., Ltd.	Yangzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Yiwu Ori-Power Medtech Co., Ltd.	YIWU Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Zhangjiagang Shengang Medical Products Co.,ltd	Zhangjiagang Jiangsu, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zhejiang Bangli Medical Products Co., Ltd.	YONGKANG CITY Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Lanhine Medical Products Ltd.	Cixi City Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, China	Manufacturer	0		0	api.fda.gov
Zonefly Medical Devices Co., Ltd.	Danyang Jiangsu, China	Exporter to the US, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd.	ZHANGJIAGANG Jiangsu, China	Manufacturer	0		0	api.fda.gov
Zhangzhou iHastek Inc.	Zhangzhou City Fujian, China	Manufacturer	0		0	api.fda.gov
Zhejiang Changdi Medical Co., Ltd.	JINHUA Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhongshan Juncheng Medical Technology Co.,Ltd	ZhongShan Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov

Updated January 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.