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Data / Medical devices / Mask, Surgical / Vietnam

FDA-registered makers of Mask, Surgical in Vietnam: 8 establishments

8 establishments in Vietnam are registered with the FDA to make Mask, Surgical (product code FXX). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Mask, Surgical
Product code
FXX
Country
Vietnam

Makers of Mask, Surgical in Vietnam

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Global Resources (vietnam) Group Limited CompanyHai Phong City, VietnamManufacturer1June 18, 2025000api.fda.gov
Intco Medical Technology Viet Nam Company LimitedDong Mai Ward Quang Ninh, VietnamManufacturer1March 30, 2021000api.fda.gov
Phu Bao Medical Co., LtdLong An Province, VietnamManufacturer1September 2, 2022000api.fda.gov
Sanmu (vietnam) Protective Products Co., LtdDuc Hoa Commune Tay Ninh, VietnamContract manufacturer, Exporter to the US, Manufacturer1March 29, 2021000api.fda.gov
Allmed Medical Textile Co.,ltd (viet Nam)Tan Lan Commune Tay Ninh, VietnamContract manufacturer0000api.fda.gov
Kim Sora CorporationHoa Khanh Ward Da Nang, VietnamManufacturer0000api.fda.gov
Nolan Medical Products Liability Limited CompanyDa Nang City, VietnamContract manufacturer0000api.fda.gov
Sanqi (Vietnam) New Material Co., LtdTan Phuoc 3 Commune Dong Thap, VietnamContract manufacturer0000api.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.