Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011391433

FEI Number

3011391433

Entity Name

SHANDONG INTCO MEDICAL PRODUCTS CO LTD

City/State/Country

Qingzhou Shandong, CN

Establishment Address

9888 Qiwang Road, Naoshan Industrial Park, Qingzhou Shandong 262500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong Intco Medical Products Co Ltd (Owner Number: 10048737)

Owner / Operator Contact Address

No. 9888 Qiwang Road, Naoshan Industrial Park, Qingzhou, CN-SD 262500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170136

PMA Number

N/A

All Registered Proprietary Names

Sterile Latex Examination Gloves Powder Free Vinyl examination glove Medical face mask Latex Examination Gloves nitrile examination glove

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2026-03-22
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2021-09-23
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-04-15
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2026-03-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-03-15
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2018-03-15

Official Correspondent

John Zhao

US Agent Details

Max Lee Email: maxli@basicmedical.com Phone: (909) 9801678

Related Public Records

Same Entity

Shandong Intco Medical Products 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
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31
K891418	C & K Mfg. & Sales Co.	LATEX EXAMINATION GLOVES, STYLE 510 LX	1989-06-22
K994255	Pt. Maja Agung Latexindo	LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE	2000-02-07
K892946	Yeou-Fwu Rubber Industrial Co., Ltd.	STERILE PATIENT EXAMINATION GLOVES	1989-08-10

Similar Registrations

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3017940518	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY	Bac Ninh, VN
1000266564	SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED.	Hat Yai Songkhla, TH
8040653	ARISTA LATINDO INDUSTRIAL, LTD. P.T.	JAKARTA BARAT, ID
3002661124	ULINE, INC.	Pleasant Prairie, WI, US
3019769825	HARTALEGA NGC SDN. BHD. (LOT 39496)	Sepang Selangor, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011391433. Last updated year: 2026. Please use registration number 3011391433 when referencing this establishment in official correspondence.