Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004133236

FEI Number

3004133236

Entity Name

JIANGXI 3L MEDICAL PRODUCTS GROUP CO., LTD

City/State/Country

Nanchang Jiangxi, CN

Establishment Address

No.599, Huoju Street, High-tech Development Zone, Nanchang Jiangxi 330029, CN

Establishment Type(s)

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

Owner / Operator

JIANGXI 3L MEDICAL PRODUCTS GROUP CO., LTD (Owner Number: 9058101)

Owner / Operator Contact Address

No.599, Huoju Street, High-tech Development Zone, Nanchang, CN-JX 330029, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Incise Drape (SP1020, SP2841, SP3535, SP5045, SP6045, SP6060, SP6085) Microscope Drape (WJ250*120J, WJ230*123T, WJ203*110J, WJ215*120J, WJ267*104T, WJ120X100, WJ150X14, WJ150X14A) LOWER VASCULAR DRAPE (FJ301060) KNEE ARTHROSCOPY DRAPE (FJ301003) C arm drape cover (195cmx111cm) PU Incise Drape (SP4045T, SP5696T, SP5260T) Cesarean Section drape Sheet (254x291cm, 254x307cm) CRANIOTOMY DRAPE (FJ301059) LAPAROSCOPY DRAPE (FJ301004) Ophthalmic Drape Sheet (FJ301006, FJ301054, FJ120X100) HEAD/NECK SET(FJ304005) THORACIC DRAPE (FJ301058) PU Incise Drape (SP1410T, SP3825T, SP3841T, SP4860T, SP7090T, SP2815T, SP2830T, SP2845T, SP5545T, SP6085T) Microscope Drape (WJ180X20A, WJ200X14A) 40g SMS FABRIC (FJ100*70) 3L SURGICAL DRAPE VERTICAL ISOLATION DRAPE (FJ302027) EXTREMITY DRAPE (FJ301055) HAND/FOOT DRAPE (FJ301056 FJ301057) 55gr laminted film drape-layer with fluid collection pouch (FJ303007, FJ120X100S) Surgical Face Mask, Model: Tie on, Ear loop Disposable Medical Face Mask Surgical Incise Drape (SP1020, SP2841, SP3535, SP5045, SP6045, SP6060, SP6085) Non-woven Surgical Tape (JD1001, JD1002, JD1003, JD1004, JD1005, JD1011, JD1012) Injection Plaster (3L-BG-801) Transparent Wound Dressing (FB1040T, FB1050T) Transparent Wound Dressing (FB0508T, FB0910T, FB0915T, FB0920T, FB0925T, FB1025T, FB1020T, FB1025T, FB1030T, FB1035T) I.V. Dressing (FT0607U, FT1012, FT1520, FT0405, FM0607, FT0907V) Silk Tape (JD3001, JD3002, JD3003, JD3004, JD3005, JD3011, JD3022) PE Transparent Surgical Tape (JD2001, JD2002, JD2003, JD2004, JD2005, JD2011, JD2012) Fixing Bandage (JC2-1000, JC4-1000, JC6-1000, JC8-1000) Adhesive Wound Dressing (FB0508, FB0910, FB0915, FB0920, FB1015, FB0925, FB1020, FB1025, FB1030, FB1035, FB1040) Soft Clothe Linner Tape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2004-01-09
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-09-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-16
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2026-06-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-08-18

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

JIANGXI 3L MEDICAL PRODUCTS GROUP 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
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
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 3004133236. Last updated year: 2026. Please use registration number 3004133236 when referencing this establishment in official correspondence.