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Data / Medical devices / Medical Glove, Specialty

Medical Glove, Specialty (LZC): 176 FDA-registered makers in 16 countries

176 establishments in 16 countries are registered with the FDA to make Medical Glove, Specialty (product code LZC, Class 1, 21 CFR 880.6250). 45 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 79 510(k) clearances under this code, the latest on January 14, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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

Makers by country

CountryMakers
Malaysia53
China38
United States36
Thailand16
Vietnam11
Indonesia10
Sri Lanka2
Cambodia2
Singapore1
Canada1
Ireland1
Italy1
India1
Austria1
Honduras1
Taiwan1

Makers of Medical Glove, Specialty

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
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer15October 11, 2020020api.fda.gov
Ansell Healthcare Products LLCReno, NV, United StatesManufacturer, Specification developer8October 23, 2019000api.fda.gov
Safeskin Medical & Scientific (thailand), Ltd.SADAO Songkhla, ThailandManufacturer, Specification developer8October 11, 2020000api.fda.gov
Kossan International Sdn BhdShah Alam Selangor, MalaysiaExporter to the US, Specification developer6November 29, 2010000api.fda.gov
WRP Asia Pacific Sdn. Bhd.SALAK TINGGI, SEPANG Selangor, MalaysiaComplaint file establishment, Contract manufacturer, Manufacturer5February 5, 2015000api.fda.gov
Yty Industry (manjung) Sdn. Bhd.SITIAWAN Perak, MalaysiaContract manufacturer, Manufacturer5September 18, 2020000api.fda.gov
Central Medicare Sdn BhdTeluk Intan Perak, MalaysiaContract manufacturer, Manufacturer4July 4, 2019000api.fda.gov
HARPS Investment Asia Pte. Ltd.Singapore Central Singapore, SingaporeExporter to the US, Manufacturer, Specification developer4March 14, 2012000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer3January 14, 2026000api.fda.gov
GMP Medicare Sdn Bhd(F25)Klang Selangor, MalaysiaContract manufacturer, Manufacturer3August 29, 2019000api.fda.gov
GP LumutSitiawan Perak, MalaysiaContract manufacturer, Manufacturer3June 27, 2018000api.fda.gov
Latexx Manufacturing Sdn. Bhd.TAIPING Perak, MalaysiaContract manufacturer, Manufacturer3March 14, 2012000api.fda.gov
Perusahaan Getah Asas Sdn. Bhd.JERAM Selangor, MalaysiaContract manufacturer, Manufacturer3November 29, 2010000api.fda.gov
Yty AchehSitiawan Perak, MalaysiaContract manufacturer, Manufacturer3June 27, 2018000api.fda.gov
Comfort Rubber Gloves Industries Sdn BhdTAIPING Perak, MalaysiaContract manufacturer, Exporter to the US, Manufacturer2May 15, 2018000api.fda.gov
Hebei Titans Hongsen Medical Technology Co.,ltdXingtai Hebei, ChinaManufacturer2August 10, 2018000api.fda.gov
JR Engineering And Medical Technologies (M) Sdn BhdRASA Selangor, MalaysiaManufacturer2August 30, 2022000api.fda.gov
TG Medical Sdn BhdKLANG Selangor, MalaysiaContract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler2August 29, 2019000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer1March 19, 2019000api.fda.gov
Ansell Seremban Sdn. BhdSeremban Negeri Sembilan, MalaysiaManufacturer1July 24, 2017000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer1May 22, 1989000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer1May 22, 1989000api.fda.gov
Brightway Holdings Sdn. Bhd.KLANG, Selangor, MalaysiaManufacturer1March 31, 2017000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer1May 22, 1989000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer1May 22, 1989000api.fda.gov
Eco Medi Glove Sdn BhdTaiping Perak, MalaysiaContract manufacturer, Manufacturer1November 13, 2003000api.fda.gov
Emerson & Co. S.R.L.GENOA Genova, ItalyManufacturer1December 23, 1998000api.fda.gov
Encompass Industries Sdn. Bhd.KEMAMAN Terengganu, MalaysiaContract manufacturer, Manufacturer1October 23, 2019000api.fda.gov
Ever Global (vietnam) Enterprise CorporationDong Nai Province, VietnamManufacturer1June 4, 2020000api.fda.gov
Ever Global (vietnam) Enterprise CorporationAn Phuoc Village Dong Nai, VietnamContract manufacturer, Manufacturer1June 4, 2020000api.fda.gov
GX Corporation Sdn Bhd (Specialty Plant)Klang Selangor, MalaysiaContract manufacturer, Manufacturer1November 2, 2009000api.fda.gov
Hartalega NGC Sdn. Bhd. (lot 39496)Sepang Selangor, MalaysiaManufacturer1June 25, 2012000api.fda.gov
Hartalega Sdn BhdBestari Jaya Selangor, MalaysiaSpecification developer1June 25, 2012000api.fda.gov
HL Rubber Industries Sdn BhdKUALA PILAH Negeri Sembilan, MalaysiaContract manufacturer, Manufacturer1May 26, 2022000api.fda.gov
Haywood Vocational Opportunities Inc.Waynesville, NC, United StatesContract manufacturer, Repackager or relabeler1November 29, 2010000api.fda.gov
I Quality Rubber Industries Sdn. Bhd.Matang Perak, MalaysiaSpecification developer1May 15, 2018000api.fda.gov
Kossan Latex Industries (M) Sdn BhdKLANG Selangor, MalaysiaContract manufacturer, Manufacturer1February 27, 2007000api.fda.gov
Maxter Glove Manufacturing Sdn BhdKLANG Selangor, MalaysiaManufacturer1May 2, 2018000api.fda.gov
Maxter Healthcare IncRosharon, TX, United StatesManufacturer1May 2, 2016000api.fda.gov
Mexpo International, Inc.Union City, CA, United StatesContract manufacturer, Manufacturer1March 5, 2018000api.fda.gov
Mundy Medical Marketing, Inc.Calabasas, CA, United StatesManufacturer, Specification developer1February 13, 1990000api.fda.gov
PT. Medisafe TechnologiesKab. Deli Serdang Sumatera Utara, IndonesiaContract manufacturer, Manufacturer1March 19, 2019000api.fda.gov
SGMP Co., Ltd.Hatyai Songkhla, ThailandContract manufacturer, Manufacturer1November 19, 2010000api.fda.gov
SW Technologies Inc.Union City, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer1November 21, 2012000api.fda.gov
Usa Scientific, Inc.Ocala, FL, United StatesRepackager or relabeler, Specification developer1November 29, 2010000api.fda.gov
3a Glove Sdn. Bhd.Senai Johor, MalaysiaManufacturer0000api.fda.gov
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
American Armor GlovesWest Columbia, SC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
American Nitrile Operations LLCGrove City, OH, United StatesManufacturer0000api.fda.gov
Anhui Intco Medical Products Co., Ltd.Huaibei Anhui, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Anrel Distribution LLCJackson, NJ, United StatesManufacturer0000api.fda.gov
Ansell (thailand) Ltd.THAILAND Krung Thep Maha Nakhon, ThailandManufacturer0000api.fda.gov
Ansell Lanka (pvt.), Ltd.BIYAGAMA Gampaha, Sri LankaManufacturer0000api.fda.gov
Ansell N.P. Sdn. Bhd.Melaka, MalaysiaManufacturer0000api.fda.gov
Arrow Medsource Group LimitedHongkong, ChinaExporter to the US, Specification developer0000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ansell Sterile Solutions Pvt. LtdErode Tamil Nadu, IndiaContract manufacturer, Contract sterilizer, Manufacturer0000api.fda.gov
Bandex Industrial Corp.Zhuhai City Guangdong, ChinaExporter to the US, Manufacturer0000api.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
BiometerPlus USA, Inc.Fremont, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Cardinal Health 222 (thailand) LimitedPLUAKDAENG Rayong, ThailandManufacturer0000api.fda.gov
Cardinal Health 222 (thailand) LimitedPLUAKDAENG Rayong, ThailandManufacturer0000api.fda.gov
Careglove Global Sdn BhdSeremban Negeri Sembilan, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
CM2Teluk Intan Perak, MalaysiaContract manufacturer0000api.fda.gov
D&M ProcurementHouston, TX, United StatesSpecification developer0000api.fda.gov
Dipped Products (thailand) LtdAMPHUR KHUN NIENG Songkhla, ThailandContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dynacare Sdn BhdSitiawan Perak, MalaysiaManufacturer0000api.fda.gov
Eco Medi Glove Sdn BhdTaiping Perak, MalaysiaContract manufacturer0000api.fda.gov
Eco Medi Glove Sdn BhdTaiping Perak, MalaysiaContract manufacturer0000api.fda.gov
Ever Global (vietnam) Enterprise CorporationLong Khanh City Dong Nai, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Gallant Quality Sdn. Bhd.Taiping, Perak, MalaysiaContract manufacturer0000api.fda.gov
GCB Medical LLCDuxbury, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Genabio Diagnostics IncBedford, MA, United StatesSpecification developer0000api.fda.gov
GMP Medicare Sdn BhdSiliau Negeri Sembilan, MalaysiaManufacturer0000api.fda.gov
Grand Work Plastic Products Co., Ltd.ZANHUANG Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangdong Kingfa Sci.&tech.co.,ltd.Qingyuan Guangdong, ChinaManufacturer, Specification developer0000api.fda.gov
Guangdong Vyimed Co., Ltd.Qingyuan Guangdong, ChinaManufacturer0000api.fda.gov
Hartalega NGC Sdn BhdSepang Selangor, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
He Chuang Plastic & Rubber Co., LtdZibo Shandong, ChinaExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Hudson Scientific LLCHudson, MI, United StatesSpecification developer0000api.fda.gov
Harps Europe ManufacturingWimpassing Niederosterreich, AustriaManufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.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
Jiangsu Cureguard Glove Co., Ltd.Ulanqab City Inner Mongolia, ChinaManufacturer0000api.fda.gov
Jiangxi Zhonghong Pulin Medical Products Co.,ltd.jiujiang Jiangxi, ChinaContract manufacturer0000api.fda.gov
Jiangsu Nanfang Medical Co., Ltd.CHANGZHOU Jiangsu, ChinaManufacturer0000api.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
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
Lingshi Hongruida Health Protection Technology Co., Ltd.Jinzhong City Shanxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Mah Sing Healthcare Sdn BhdKlang Selangor, MalaysiaManufacturer0000api.fda.gov
Matang MFG. Sdn. Bhd.MERLIMAU Melaka, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Medical Action Industries, Inc. 306Arden, NC, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification 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
Motex Healthcare (anhui) Co., Ltd.Guangde City, Xuancheng City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
Onetexx Sdn BhdKamunting Perak, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Opus Gloves Co.,ltd.shanghai, ChinaContract manufacturer0000api.fda.gov
P.T. Maja Agung LatexindoSUNGGAL DELI SERDANG Sumatera Utara, IndonesiaManufacturer0000api.fda.gov
Pacewell Asia Sdn. Bhd.Batu Gajah Perak, MalaysiaContract manufacturer0000api.fda.gov
Premier Medical Gloves FactoryWeifang Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
Prestige AmeritechNorth Richland Hills, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.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. Sintong Unigolden GloveKISARAN Sumatera Utara, IndonesiaContract manufacturer, Manufacturer0000api.fda.gov
Pt.shamrock Manufacturing Corp.MEDAN Sumatera Utara, IndonesiaManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Riverstone Resources Sdn BhdTAIPING Perak, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Riverstone Resources Sdn. Bhd.BUKIT BERUNTUNG, Selangor, MalaysiaContract manufacturer, 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
SAS Safety Corp.Cerritos, CA, United StatesReprocessor0000api.fda.gov
Shandong Blue Sail Health Technology Co., LtdWeifang Shandong, ChinaManufacturer0000api.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 Intco Medical Products Co LtdQingzhou Shandong, ChinaManufacturer0000api.fda.gov
Shandong Xingyu Gloves Co., LtdGaomi Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Motex Healthcare Co., Ltd.Shanghai, 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
Stevimed Medical Joint Stock CompanyCan Giuoc Commune Tay Ninh, VietnamManufacturer0000api.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
Sundex CorporationTaipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
SafeSource Direct Glove PlantBroussard, LA, United StatesManufacturer0000api.fda.gov
Tekmedic (M) Sdn BhdMelaka, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Terang Nusa (malaysia) Sdn. Bhd.Kota Bharu Kelantan, MalaysiaContract manufacturer0000api.fda.gov
Thanh Hoa Medical Technology Co., Ltd.QUANG TRUNG WARD Thanh Hoa, VietnamExporter to the US, Manufacturer0000api.fda.gov
TNG Worldwide IncNew Hudson, MI, United StatesSpecification developer0000api.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
True Glove FactoryWeifang Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
Us Medical Glove CompanyHarvard, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
US Paper Mill LLCChillicothe, OH, United StatesComplaint file establishment, Manufacturer0000api.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 manufacturer, 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
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
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
Zhongnuo Medical Products Co.,ltd.tangshan Hebei, ChinaContract manufacturer0000api.fda.gov
Zibo Blue Sail Health Technology Co., LtdZibo Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
Zibo Chengxun Automatic Device Co., LtdZibo Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
Zibo Kaiyue Mould Technology Co., LtdZibo Shandong, ChinaExporter to the US, Specification developer0000api.fda.gov
Zibo Lanhua Medical Packaging Material Co., LtdZibo Shandong, ChinaManufacturer0000api.fda.gov
Zibo Sinocare Plastic Products Co., Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zibo Blue Sail Innovation Co., LtdZibo Shandong, ChinaManufacturer0000api.fda.gov

Updated January 14, 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.