Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680357

FEI Number

3004829691

Entity Name

DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY

City/State/Country

DONG GUAN CITY Guangdong, CN

Establishment Address

No. 17, Banhu Rd, /No.54 Hong Sheng Road, Diao Lang Village, Huang Jiang Town,, DONG GUAN CITY Guangdong 523750, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY (Owner Number: 9008465)

Owner / Operator Contact Address

BAN HU INDUSTRIAL DISTRICT, Huang Jiang Town, Dongguan,, CN-GD 523753, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dressing Compression L4 surgical gowns Face Mask Prevention Plus gown PP Gown LAB JACKET Tracheal tube fixation device N95 Particulate Respirator surgical drape Bandage, cast Bandage, Cast DRAPE SHEET Surgical mask with Fluid Shield N95 Particulate Respirator Particulate Respirator cover bedding Surgical mask Sterilization Wrap PE Coated Gowns Dressing ABSORBENT TOWEL surgical instrument DRAIN BAG POUCH Surgical Drapes Surgical Dapes NON-SKID SHOE COVER Hydrophilic Dressing Wound Accessories Kit UNIVERSAL I PACK DISPOSABLE BOUFFANT CAPS LAB JACKET LAB COAT SCRUBS COVERALL Gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2013-07-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-09-16
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-07-29
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-09-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-02-21
FME	Gown, Examination	General Hospital	Class 1	880.6265	1998-04-08
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2011-12-20
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-09-07
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-17
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2015-06-16
EYX	Drape, Pure Latex Sheet, With Self-Retaining Finger Cot	General, Plastic Surgery	Class 2	878.4370	2022-08-18
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-11-09
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-11-15
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2008-01-15
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2008-07-29
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-07-12
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2011-06-29
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2009-11-03
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-01-28
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-02-12
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2011-07-07
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-01-29
EYH	Table, Cysto, Non-Electrical	Gastroenterology, Urology	Class 1	876.4890	2013-05-02
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2009-06-17
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	1995-02-28
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-08-21
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2026-03-03
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2010-03-01
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	1995-03-13
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2007-07-31
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-02-21

Official Correspondent

SHERRY HUANG

US Agent Details

GARY WANG Business: MAYTEX CORP. Email: maytex18@aol.com Phone: (510) 8874888

Related Public Records

Same Entity

DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY

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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680357. Last updated year: 2026. Please use registration number 9680357 when referencing this establishment in official correspondence.