Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006437555

FEI Number

3006437555

Entity Name

KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.

City/State/Country

KUNSHAN CITY Jiangsu, CN

Establishment Address

No.895 Xinle Road, Dianshanhu Town, KUNSHAN CITY Jiangsu 215345, CN

Establishment Type(s)

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

Owner / Operator

KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. (Owner Number: 9094909)

Owner / Operator Contact Address

No. 895 Xinle Road,, Dianshanhu Town, KUNSHAN CITY, CN-JS 215345, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112136

PMA Number

N/A

All Registered Proprietary Names

Coverall Surgical Suit JIEHONG Non-surgerical isolation gown Medical disposal protective clothing (coverall)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-12-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-12-27
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2010-04-27
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2009-03-31
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-01-09
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-04-27
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-12-15
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-01-28
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-01-28
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2011-03-17
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-31
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2019-12-18
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2012-03-16
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2012-12-26
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2019-09-20
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2011-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

KUNSHAN JIEHONG NONWOVEN PRODUCT 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006437555. Last updated year: 2026. Please use registration number 3006437555 when referencing this establishment in official correspondence.