Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038613790

FEI Number

3038613790

Entity Name

JIE GAO MEDICAL PLASTIC PRODUCTS (MALAYSIA) SDN. BHD.

City/State/Country

Klang Selangor, MY

Establishment Address

No. 4, Jalan Tun Perak 5/KU16, Taman Perindustrian Perdana, Pelabuhan Klang, Selangor Darul Ehsan, Klang Selangor 4200, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JIE GAO MEDICAL PLASTIC PRODUCTS (MALAYSIA) SDN. BHD. (Owner Number: 10093557)

Owner / Operator Contact Address

No. 4, Jalan Tun Perak 5/KU16, Taman Perindustrian Perdana, Pelabuhan Klang, Selangor Darul Ehsan, Klang, MY-10 42000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Container, Specimen, Sterile Sharps Container Tray, Surgical Basin Emesis Container, Specimen, Non-Sterile Bedpan Liner, Semi-Rigid Outer Canister, Semi-Rigid Mixer, Cement, For Clinical Use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2025-06-03
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2025-06-03
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-06-03
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2025-08-11
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2025-06-03
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2025-06-03
FOB	Bedpan	General Hospital	Class 1	880.6730	2025-06-03
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2025-06-03
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2025-06-03

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

JIE GAO MEDICAL PLASTIC PRODUCTS (MALAYSIA) SDN. BHD.

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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

Similar Registrations

Registration Number	Establishment Name	Location
3006847360	Corning Science Mexico	Reynosa Tamaulipas, MX
3010610454	JinJiang Honghai Plastics Industrial Co., Ltd.	Jinjiang, Fujian, CN
3027655366	SEAIN SOLUTION LTD.	Taipei, TW
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX
3018077536	SUPERA FULFILLMENT LLC	Houston, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038613790. Last updated year: 2026. Please use registration number 3038613790 when referencing this establishment in official correspondence.