Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004362278

FEI Number

3004362278

Entity Name

Sino Protection (Hefei) Medical Products Co. ltd.

City/State/Country

HEFEI Anhui, CN

Establishment Address

Area B, XINZHAN Industrial Park, XINGHUO road, HEFEI Anhui --230011, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SINO PROTECTION INDUSTRIAL LTD. (Owner Number: 9046244)

Owner / Operator Contact Address

FLAT 1, 13/F, HING WAN COMM, BLDG., 25 PARKS ST., KOWLOON, HK-NOTA --, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPT-2208SMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2014-11-02
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-09-22
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2025-09-10
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2003-12-03
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-03-24
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2018-02-07
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-09-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2007-10-30
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2024-01-15
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2008-05-07
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2020-08-25
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2020-08-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2003-12-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-09-22
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2003-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

SUSAN BARNETT Business: SUSAN BARNETT Email: steveandsusan@aol.com Phone: (319) 3210851

Related Public Records

Same Entity

SINO PROTECTION INDUSTRIAL LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3042245424	Sino Protection Holding Co Limited Egypt Branch Ismailia Free Zone	Ismailia Al Isma'iliyah, EG

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004362278. Last updated year: 2026. Please use registration number 3004362278 when referencing this establishment in official correspondence.