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Data / Medical devices / Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection (QPC): 13 FDA-registered makers in 6 countries

13 establishments in 6 countries are registered with the FDA to make Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection (product code QPC, Class 2, 21 CFR 878.4040). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on September 11, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
QPC
Device class
2
Regulation
878.4040
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States4
China3
Cambodia2
Vietnam2
Hong Kong1
Mexico1

Makers of Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

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
Polyconversions, Inc.Champaign, IL, United StatesManufacturer2December 16, 2025000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1April 26, 2019000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesManufacturer, Specification developer1July 7, 2017000api.fda.gov
Hubei Xinxin Non-Woven Co., LtdXiantao Hubei, ChinaManufacturer1April 26, 2019000api.fda.gov
Kenpax International LimitedKowloon, Hong KongSpecification developer1August 8, 2023000api.fda.gov
Lianyungang Anson Non-woven Product Co., Ltd.Lianyungang Jiangsu, ChinaManufacturer1August 8, 2023000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1March 5, 2024000api.fda.gov
Andersen Industries Co., Ltd.Angsnoul District Kandal, CambodiaContract manufacturer0000api.fda.gov
Cam A P I Medical Co., Ltd.Angsnuol District Kandal, CambodiaContract manufacturer0000api.fda.gov
Jiangsu Wonderful Nonwoven Technology Co., Ltd.Suqian City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Viet Nam Hong Duc Medical Products Limited Liability Co.Xa Duc Hoa Tay Ninh, VietnamContract manufacturer0000api.fda.gov
Viet Nam Hong Duc Medical Products Limited Liability CompanyDuc Hoa Commune Tay Ninh, VietnamContract manufacturer0000api.fda.gov
Wear Tex S. De R.L. De C.V.Torreon Coahuila, MexicoContract manufacturer0000api.fda.gov

Updated September 11, 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.