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Data / Medical devices / Non-Surgical Gown / United States

FDA-registered makers of Non-Surgical Gown in the United States: 63 establishments

63 establishments in the United States are registered with the FDA to make Non-Surgical Gown (product code OEA). 0 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.

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Device
Non-Surgical Gown
Product code
OEA
Country
United States

Makers of Non-Surgical Gown in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
718 Ek Inc.Brooklyn, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Allcare, Inc.St Charles, IL, United StatesSpecification developer0000api.fda.gov
American Dawn Inc.Compton, CA, United StatesSpecification developer0000api.fda.gov
Ansell Healthcare Products LLCReno, NV, United StatesSpecification developer0000api.fda.gov
Anzen HealthChicago, IL, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesSpecification developer0000api.fda.gov
AZAC GroupCity of Industry, CA, United StatesSpecification developer0000api.fda.gov
Apex Aseptic ProductsVoorhees, NJ, United StatesSpecification developer0000api.fda.gov
Baluster LLCMountain View, AR, United StatesRepackager or relabeler, Reprocessor0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
Boston Bgecare IncPittsfield, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Cellucap Manufacturing Co.Phila, PA, United StatesSpecification developer0000api.fda.gov
Covr Medical, LLCRochester, MN, United StatesSpecification developer0000api.fda.gov
Curt G. Joa, Inc.Sheboygan Falls, WI, United StatesContract manufacturer0000api.fda.gov
Customfab, Inc.Anaheim, CA, United StatesContract manufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
DePre, LLCPowell, TN, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Essential Safety PPE, LLCHouston, TX, United StatesManufacturer0000api.fda.gov
GD Group USA CompanyBartlett, IL, United StatesSpecification developer0000api.fda.gov
Gredale, LLCLos Angeles, CA, United StatesManufacturer0000api.fda.gov
Health Supply Us LLCMooresville, NC, United StatesSpecification developer0000api.fda.gov
Heartland Manufacturing, Inc.Long Island City, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Hexa DentalCommerce, CA, United StatesManufacturer for export0000api.fda.gov
HPK IndustriesFrankfort, NY, United StatesManufacturer0000api.fda.gov
Haywood Vocational Opportunities Inc.Waynesville, NC, United StatesContract manufacturer0000api.fda.gov
Hilo Industries LLCMesa, AZ, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Infab, LLC.Camarillo, CA, United StatesManufacturer0000api.fda.gov
Infinitus Medical Technologies LLCHolly Springs, NC, United StatesManufacturer, Specification developer0000api.fda.gov
IsoguardianAlbany, NY, United StatesSpecification developer0000api.fda.gov
Koos Medical Innovations, Inc.Ankeny, IA, United StatesSpecification developer0000api.fda.gov
Laguna ScientificAliso Viejo, CA, United StatesSpecification developer0000api.fda.gov
Little Rapids CorporationGreen Bay, WI, United StatesSpecification developer0000api.fda.gov
Maddox Defense, Inc.Houston, TX, United StatesManufacturer0000api.fda.gov
Maddox Medical CorpHouston, TX, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Mip UsaBolingbrook, IL, United StatesManufacturer0000api.fda.gov
Mawadda, LLCSaint Paul, MN, United StatesManufacturer0000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer0000api.fda.gov
New York Embroidery StudioBrooklyn, NY, United StatesManufacturer0010api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Obbomed Group LLCPomona, CA, United StatesSpecification developer0000api.fda.gov
Polyconversions, Inc.Champaign, IL, United StatesManufacturer0000api.fda.gov
Prescient Logistics LLCSanford, FL, United StatesSpecification developer0000api.fda.gov
Proguard Health Inc.Los Angeles, CA, United StatesManufacturer0000api.fda.gov
Protection Products, Inc.Hickory, NC, United StatesSpecification developer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Safesource DirectBroussard, LA, United StatesManufacturer0000api.fda.gov
Standard Textile Co., Inc.Cincinnati, OH, United StatesSpecification developer0000api.fda.gov
Sun-Scientific Inc.Dobbs Ferry, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Superior Group Of Companies, Inc.Saint Petersburg, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Sloan MedicalOmaha, NE, United StatesManufacturer, Specification developer0000api.fda.gov
Sterling Medical ProductsProphetstown, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
StringKingCarson, CA, United StatesManufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Taromed IncLos Angeles, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
Two One Two New York, Inc.Edgewood, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Xodus Medical, Inc.New Kensington, PA, United StatesSpecification developer0000api.fda.gov

Updated November 3, 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.