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Data / Medical devices / Patient Personal Hygiene Kit

Patient Personal Hygiene Kit (NSB): 42 FDA-registered makers in 6 countries

42 establishments in 6 countries are registered with the FDA to make Patient Personal Hygiene Kit (product code NSB, Class 1, 21 CFR 872.6855). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 16 recall events (2 Class I). FDA data exported November 2, 2026.

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Product code
NSB
Device class
1
Regulation
872.6855
Medical specialty
Dental

Makers by country

CountryMakers
United States16
China16
Mexico7
Honduras1
Cambodia1
India1

Makers of Patient Personal Hygiene Kit

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
AVENT S. de R.L. de C.V.NOGALES Sonora, MexicoManufacturer0000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Care Line, Inc.Greenbrier, TN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Cordica Medical, Inc.Morristown, TN, United StatesContract manufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Epi-Hab Phoenix, IncPhoenix, AZ, United StatesContract manufacturer0000api.fda.gov
Hangzhou Wise Medical Device Co.,ltdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Heitco, Inc.Avon, OH, United StatesManufacturer0000api.fda.gov
Henan Baistra Medical Devices LimitedZhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Hubei Qianjiang Kingphar Medical Material Co., LtdQianjiang, Hubei, ChinaManufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Huakang Packaging Technology Co., Ltd.Prey Nob Preah Sihanouk, CambodiaManufacturer0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoComplaint file establishment, Contract manufacturer0000api.fda.gov
Jiaoyue Pharmaceutical (huizhou) Co.ltdHuizhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kentron Health Care, Inc.Springfield, TN, United StatesManufacturer0000api.fda.gov
La Ada de AcunaCIUDAD DE ACUNA Coahuila, MexicoManufacturer0000api.fda.gov
Medi-Dyne Healthcare Products, Inc.Colleyville, TX, United StatesSpecification developer0000api.fda.gov
Medical Action Industries, Inc. 306Arden, NC, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
MEDLINE INDUSTRIES, LP - LaredoLaredo, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medline Industries, LP - SPTWaukegan, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medline Industries, LP - Mexicali (MXC)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Medline Soluciones MedicasNuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
Ningbo Cooskin Stationery Co., LtdNingbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Oralkleen LLCPhoenix, AZ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Productos Medline S.A. De C.V.NUEVO LAREDO Tamaulipas, MexicoManufacturer0000api.fda.gov
Rosemarie Products Company, LLCMason, OH, United StatesSpecification developer0000api.fda.gov
Sage Products LLCCary, IL, United StatesManufacturer0010api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Huayue Packaging Products Co., Ltd.Fengxian District, Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Scope Medical Devices Private LimitedAmbala City Haryana, IndiaManufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Repackager or relabeler, Specification developer0000api.fda.gov
Westmed de Mexico, S.A de C.VMAGDALENA Sonora, MexicoContract manufacturer0000api.fda.gov
Xiantao Generalcare Protection Products Co.,ltdXiantao City Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yiwu Botai Import & ExportYiwu Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.Yang Jiao Lang Zin'an Town Zhejiang, 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.