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Data / Medical devices / Gown, Surgical / United States

FDA-registered makers of Gown, Surgical in the United States: 25 establishments

25 establishments in the United States are registered with the FDA to make Gown, Surgical (product code FYA). 20 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Gown, Surgical
Product code
FYA
Country
United States

Makers of Gown, Surgical in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer16July 21, 2021000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer10April 28, 2026000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer9February 26, 2025040api.fda.gov
Customed, Inc.Fajardo, PR, United StatesManufacturer, Repackager or relabeler6June 12, 2012031api.fda.gov
Standard Textile Co., Inc.Cincinnati, OH, United StatesSpecification developer6May 5, 2005000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer6October 16, 2024000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer2September 17, 1996010api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesComplaint file establishment, Specification developer2January 14, 1999000api.fda.gov
Zimmer Surgical, Inc.Dover, OH, United StatesManufacturer, Specification developer2October 15, 2019000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer1October 20, 1997000api.fda.gov
Atlanta Healthcare ServicesLawrenceville, GA, United StatesRepackager or relabeler, Specification developer1October 7, 1994000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer1February 21, 2022000api.fda.gov
Boston Scientific CorporationJohns Creek, GA, United StatesManufacturer1February 21, 2022000api.fda.gov
Essential Safety PPE, LLCHouston, TX, United StatesManufacturer1December 12, 2012000api.fda.gov
GCB Medical LLCDuxbury, MA, United StatesComplaint file establishment, Specification developer1May 11, 2022000api.fda.gov
Hilo Industries LLCMesa, AZ, United StatesComplaint file establishment, Manufacturer, Specification developer1February 4, 2011000api.fda.gov
Intl. Medsurg Connection, Inc.Schaumburg, IL, United StatesSpecification developer1November 17, 2005000api.fda.gov
Syntech, Int'l Inc.Irvine, CA, United StatesManufacturer1October 18, 2004000api.fda.gov
Sklar CorporationMalvern, PA, United StatesRepackager or relabeler, Specification developer1April 24, 2009000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer1May 24, 2007000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer0000api.fda.gov
Gredale, LLCLos Angeles, CA, United StatesContract manufacturer0000api.fda.gov
Midwest Sterilization Corp.Laredo, TX, United StatesContract manufacturer0000api.fda.gov
New York Embroidery StudioBrooklyn, NY, United StatesContract manufacturer0000api.fda.gov
Qsum Biopsy Disposables LLCPequot Lakes, MN, United StatesComplaint file establishment, Specification 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.