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Data / Medical devices / Fentanyl And Other Opioid Protection Glove

Fentanyl And Other Opioid Protection Glove (QDO): 113 FDA-registered makers in 10 countries

113 establishments in 10 countries are registered with the FDA to make Fentanyl And Other Opioid Protection Glove (product code QDO, Class 1, 21 CFR 880.6250). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
QDO
Device class
1
Regulation
880.6250
Medical specialty
General Hospital

Makers by country

CountryMakers
Malaysia40
China21
United States16
Thailand12
Vietnam10
Indonesia9
Cambodia2
Canada1
Singapore1
Sri Lanka1

Makers of Fentanyl And Other Opioid Protection Glove

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
4 Cascade Partners, LLCRenton, WA, United StatesManufacturer0000api.fda.gov
AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.)SUNGAI PETANI Kedah, MalaysiaManufacturer0000api.fda.gov
Alcatron Gloves FactoryWeifang Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer0000api.fda.gov
American Armor GlovesWest Columbia, SC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
American Nitrile Operations LLCGrove City, OH, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Anhui Intco Medical Products Co., Ltd.Huaibei Anhui, ChinaManufacturer0000api.fda.gov
Anrel Distribution LLCJackson, NJ, United StatesManufacturer0000api.fda.gov
Ansell (thailand) Ltd.THAILAND Krung Thep Maha Nakhon, ThailandManufacturer0000api.fda.gov
Ansell Healthcare Products LLCReno, NV, United StatesManufacturer, Specification developer0000api.fda.gov
Ansell Seremban Sdn. BhdSeremban Negeri Sembilan, MalaysiaManufacturer0000api.fda.gov
Basic International Viet Nam Co.,ltdQUANG TRUNG WARD Thanh Hoa, VietnamManufacturer0000api.fda.gov
Bay MedicalBrisbane, CA, United StatesSpecification developer0000api.fda.gov
Better Care Plastic Technology Co., Ltd.Shenze County Hebei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Careglove Global Sdn BhdSeremban Negeri Sembilan, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Central Medicare Sdn BhdTeluk Intan Perak, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Comfort Rubber Gloves Industries Sdn BhdTAIPING Perak, MalaysiaManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
D&M ProcurementHouston, TX, United StatesSpecification developer0000api.fda.gov
Eco Medi Glove Sdn BhdTaiping Perak, MalaysiaContract manufacturer0000api.fda.gov
Eco Medi Glove Sdn BhdTaiping Perak, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Encompass Industries Sdn. Bhd.KEMAMAN Terengganu, MalaysiaContract manufacturer0000api.fda.gov
Ever Global (vietnam) Enterprise CorporationDong Nai Province, VietnamManufacturer0000api.fda.gov
Ever Global (vietnam) Enterprise CorporationLong Khanh City Dong Nai, VietnamContract manufacturer0000api.fda.gov
Ever Global (vietnam) Enterprise CorporationAn Phuoc Village Dong Nai, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Gallant Quality Sdn. Bhd.Taiping, Perak, MalaysiaContract manufacturer0000api.fda.gov
Genabio Diagnostics IncBedford, MA, United StatesSpecification developer0000api.fda.gov
GMP Medicare Sdn BhdSiliau Negeri Sembilan, MalaysiaManufacturer0000api.fda.gov
GMP Medicare Sdn Bhd(F25)Klang Selangor, MalaysiaManufacturer0000api.fda.gov
GP LumutSitiawan Perak, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Grand Work Plastic Products Co., Ltd.ZANHUANG Hebei, ChinaManufacturer0000api.fda.gov
Guangdong Kingfa Sci.&tech.co.,ltd.Qingyuan Guangdong, ChinaManufacturer, Specification developer0000api.fda.gov
Guangdong Vyimed Co., Ltd.Qingyuan Guangdong, ChinaManufacturer0000api.fda.gov
GX Corporation Sdn Bhd (Specialty Plant)Klang Selangor, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
HARPS Investment Asia Pte. Ltd.Singapore Central Singapore, SingaporeExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Hartalega NGC Sdn BhdSepang Selangor, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Hartalega NGC Sdn. Bhd. (lot 39496)Sepang Selangor, MalaysiaManufacturer0000api.fda.gov
Hartalega Sdn BhdBestari Jaya Selangor, MalaysiaSpecification developer0000api.fda.gov
Ideal Quality Sdn BhdKlang Selangor, MalaysiaContract manufacturer0000api.fda.gov
Ideal Quality Sdn BhdKLANG Selangor, MalaysiaContract manufacturer0000api.fda.gov
Jasmine GloveHat Yai Songkhla, ThailandManufacturer0000api.fda.gov
JR Engineering And Medical Technologies (M) Sdn BhdRASA Selangor, MalaysiaManufacturer0000api.fda.gov
Kanglongda Vietnam Protection Technology Company LimitedPhong Dien Thua Thien-Hue, VietnamManufacturer0000api.fda.gov
Kl-Kepong Rubber Products Sdn. Bhd.IPOH Perak, MalaysiaContract manufacturer0000api.fda.gov
Koon Seng Sdn BhdTangkak Johor, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Kossan International Sdn BhdShah Alam Selangor, MalaysiaExporter to the US, Specification developer0000api.fda.gov
Kossan Latex Industries (M) Sdn BhdKLANG Selangor, MalaysiaContract manufacturer0000api.fda.gov
KSG Medicare Sdn BhdTangkak Johor, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Labsource, IncNorthlake, IL, United StatesSpecification developer0000api.fda.gov
Lalan Rubbers (pvt) Ltd.Malwana Gampaha, Sri LankaContract manufacturer0000api.fda.gov
Latexx Manufacturing Sdn. Bhd.TAIPING Perak, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Lingshi Hongruida Health Protection Technology Co., Ltd.Jinzhong City Shanxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Mah Sing Healthcare Sdn BhdKlang Selangor, MalaysiaManufacturer0000api.fda.gov
Maxter Healthcare IncRosharon, TX, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtecs Msez Corp., Ltd.Krong Bavet Svay Rieng, CambodiaExporter to the US, Manufacturer0000api.fda.gov
Mercator Medical (thailand) Ltd.Ratthaphum Songkhla, ThailandExporter to the US, Manufacturer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Onetexx Sdn BhdKamunting Perak, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Opus Gloves Co.,ltd.shanghai, ChinaContract manufacturer0000api.fda.gov
Perusahaan Getah Asas Sdn. Bhd.JERAM Selangor, MalaysiaContract manufacturer0000api.fda.gov
Premier Medical Gloves FactoryWeifang Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
Professional Latex Sdn BhdKamunting Perak, MalaysiaManufacturer0000api.fda.gov
Professional Latex Sdn. Bhd.KAMUNTING Perak, MalaysiaManufacturer0000api.fda.gov
PT Basic International SumateraSimalungun Regency Sumatera Utara, IndonesiaManufacturer0000api.fda.gov
PT Greatview TechnologiesSimalungun Sumatera Utara, IndonesiaManufacturer0000api.fda.gov
PT Healthguard TechnologiesSimalungun Sumatera Utara, IndonesiaExporter to the US, Manufacturer0000api.fda.gov
PT K-Tech IndustriesSimalungun Sumatera Utara, IndonesiaExporter to the US, Manufacturer0000api.fda.gov
PT Newpoint TechnologySimalungun Sumatera Utara, IndonesiaExporter to the US, Manufacturer0000api.fda.gov
PT Ywanjan TechnologyPelalawan Regency Riau, IndonesiaExporter to the US, Manufacturer0000api.fda.gov
PT. Medisafe TechnologiesKab. Deli Serdang Sumatera Utara, IndonesiaManufacturer0000api.fda.gov
PT. Sintong Unigolden GloveKISARAN Sumatera Utara, IndonesiaContract manufacturer0000api.fda.gov
Pt.shamrock Manufacturing Corp.MEDAN Sumatera Utara, IndonesiaManufacturer0000api.fda.gov
Riverstone Resources Sdn BhdTAIPING Perak, MalaysiaContract manufacturer0000api.fda.gov
Riverstone Resources Sdn. Bhd.BUKIT BERUNTUNG, Selangor, MalaysiaContract manufacturer0000api.fda.gov
RMKH Glove (cambodia) Co., Ltd.Bavet City Svay Rieng, CambodiaExporter to the US, Manufacturer0000api.fda.gov
S&S Glove CorporationHo Chi Minh City, VietnamManufacturer0000api.fda.gov
S&S Glove Corporation- Branch 1Ho Chi Minh City Ba Ria-Vung Tau, VietnamContract manufacturer0000api.fda.gov
Safeskin Medical & Scientific (thailand), Ltd.SADAO Songkhla, ThailandManufacturer0000api.fda.gov
Shandong Hengya Packaging Printing Co.,ltdWeifang Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
Shandong Hysure Safety Tech Co., LtdWeifang City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shandong Xingyu Gloves Co., LtdGaomi Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanxi Hongjin Plastic Technology Co., LtdLinfen Shanxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Sna Safehealth Solutions Inc.Monrovia, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sri Trang Gloves (thailand) Public Company Limited.Hat Yai Songkhla, ThailandExporter to the US, Specification developer0000api.fda.gov
STGT AnvSadao Songkhla, ThailandManufacturer0000api.fda.gov
STGT CPPathio Chumphon, ThailandManufacturer0000api.fda.gov
STGT PS1Sadao Songkhla, ThailandManufacturer0000api.fda.gov
STGT SR3Kanchanadit Surat Thani, ThailandManufacturer0000api.fda.gov
STGT Surat ThaniPhlai Wat , Kanchanadit Surat Thani, ThailandManufacturer0000api.fda.gov
SW Technologies Inc.Union City, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer0000api.fda.gov
TG Medical Sdn BhdKLANG Selangor, MalaysiaExporter to the US, Manufacturer0000api.fda.gov
Thanh Hoa Medical Technology Co., Ltd.QUANG TRUNG WARD Thanh Hoa, VietnamExporter to the US, Manufacturer0000api.fda.gov
Top Glove Medical (thailand) Co., Ltd.Sadao District Songkhla, ThailandContract manufacturer, Manufacturer0000api.fda.gov
Top Glove Sdn. Bhd.KLANG Selangor, MalaysiaManufacturer0000api.fda.gov
Vanda GlovePahtong, Hat Yai Songkhla, ThailandManufacturer0000api.fda.gov
Vietmedical Product Co., Ltd.QUANG TRUNG WARD Thanh Hoa, VietnamExporter to the US, Manufacturer0000api.fda.gov
Vietwell Technology Vietnam Co., Ltd.Bim Son Thanh Hoa, VietnamExporter to the US, Manufacturer0000api.fda.gov
Wear Safe (malaysia) Sdn BhdKLANG Selangor, MalaysiaContract manufacturer0000api.fda.gov
Wear Safe (malaysia) Sdn. Bhd.KLANG Selangor, MalaysiaContract manufacturer0000api.fda.gov
Wear Safe (malaysia) Sdn. Bhd.-Facility IiKlang Selangor, MalaysiaContract manufacturer0000api.fda.gov
Weifang Tailai Steel Structure Engineering Co., LtdWeifang Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
WRP Asia Pacific Sdn. Bhd.SALAK TINGGI, SEPANG Selangor, MalaysiaManufacturer0000api.fda.gov
Xingyu Medical Tech Co.,ltdWeifang City Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Xinwei (shandong) Plastic And Rubber Products Co Ltd.Zibo Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yty AchehSitiawan Perak, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Yty Industry (manjung) Sdn. Bhd.SITIAWAN Perak, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Yue Kang Anhui Medical Products Co.,ltdhuaibei Anhui, ChinaContract manufacturer0000api.fda.gov
Zhangjiagang Dayu Rubber Products Co., Ltd.ZHANGJIAGANG CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
Zhonghong Pulin Medical Products Co.,ltd.Tangshan Hebei, ChinaManufacturer0000api.fda.gov
Zibo Chengxun Automatic Device Co., LtdZibo Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
Zibo Lanhua Medical Packaging Material Co., LtdZibo Shandong, ChinaManufacturer0000api.fda.gov

Updated November 2, 2026. 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.