Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019848304

FEI Number

3019848304

Entity Name

SANMU (VIETNAM) PROTECTIVE PRODUCTS CO., LTD

City/State/Country

Duc Hoa Commune Tay Ninh, VN

Establishment Address

Lot C1, Road No. 8, Hai Son Industrial Park (Phase 3&4), Binh Tien 2 Hamlet, Duc Hoa Commune Tay Ninh 82700, VN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SANMU (VIETNAM) PROTECTIVE PRODUCTS CO., LTD (Owner Number: 10082398)

Owner / Operator Contact Address

No. 11, Lot 2-4-6-8, An Ha Street, Tan Duc Industrial Park, Duc Hoa Commune, VN-37 82700, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Mask CSR Wrap Scrub suit CSR Wrap Surgical Mask Shoe cover CSR Wrap Surgical Mask Surgical Mask Surgical masks CSR Wrap Gemini Sterilization Wrap Doctor cap Professional towels Exam table paper Disposable Medical Bedding Patient examination gown Surgical Mask Surgical Drape Isolation gown, Protective coverall CSR Wrap Coverall

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-08
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-11-07
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-07-22
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-11-07
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-08
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2021-07-22
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-11-07
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-07
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-07
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-06-30
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-11-07
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-09-08
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-07-22
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2026-05-05
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-11-08
FME	Gown, Examination	General Hospital	Class 1	880.6265	2021-07-22
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-01-09
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-11-08
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2021-07-22
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-11-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-06-12

Official Correspondent

Lei Xia

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (571) 4072862

Related Public Records

Same Entity

SANMU (VIETNAM) PROTECTIVE PRODUCTS CO., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019848304. Last updated year: 2026. Please use registration number 3019848304 when referencing this establishment in official correspondence.