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Data / Medical devices / Gown, Examination / United States

FDA-registered makers of Gown, Examination in the United States: 35 establishments

35 establishments in the United States are registered with the FDA to make Gown, Examination (product code FME). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Gown, Examination
Product code
FME
Country
United States

Makers of Gown, Examination in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Adroit Medical Systems, Inc.Loudon, TN, United StatesManufacturer0000api.fda.gov
Allcare, Inc.St Charles, IL, United StatesSpecification developer0000api.fda.gov
Alphaprotech, Inc.Nogales, AZ, United StatesSpecification developer0000api.fda.gov
American Dawn Inc.Compton, CA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesSpecification developer0000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Border Opportunity Saver Systems, Inc.Del Rio, TX, United StatesSpecification developer0000api.fda.gov
Casco Manufacturing Solutions, Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Core Products International IncChetek, WI, United StatesManufacturer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Fabrication Ent., Inc.Elmsford, NY, United StatesManufacturer0000api.fda.gov
GD Group USA CompanyBartlett, IL, United StatesSpecification developer0000api.fda.gov
Hartford HealthcareHartford, CT, United StatesSpecification developer0000api.fda.gov
HK Surgical, Inc.San Clemente, CA, United StatesSpecification developer0000api.fda.gov
HPK IndustriesFrankfort, NY, United StatesManufacturer0000api.fda.gov
Halyard North Carolina, LLCLinwood, NC, United StatesManufacturer0000api.fda.gov
Little Rapids CorporationGreen Bay, WI, United StatesManufacturer, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Mip UsaBolingbrook, IL, United StatesSpecification developer0000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer0000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer0000api.fda.gov
Nurses Choice Corp.Wilmington, NC, United StatesManufacturer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Patientstyle Medical LLCSan Leandro, CA, United StatesManufacturer0000api.fda.gov
Prestige AmeritechNorth Richland Hills, TX, United StatesManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Shah SafariSeattle, WA, United StatesContract manufacturer0000api.fda.gov
Standard Textile Co., Inc.Cincinnati, OH, United StatesSpecification developer0000api.fda.gov
Superior Group Of Companies, Inc.Saint Petersburg, FL, United StatesSpecification developer0000api.fda.gov
Small Beginnings Inc.Hesperia, CA, United StatesManufacturer0000api.fda.gov
Sterling Medical ProductsProphetstown, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.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.