Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028162329

FEI Number

3028162329

Entity Name

XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO LTD.

City/State/Country

Zibo Shandong, CN

Establishment Address

41 Shuangshan Road, Boshan District, Zibo Shandong 255000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xinwei (Shandong) Plastic and Rubber Products Co Ltd. (Owner Number: 10088635)

Owner / Operator Contact Address

41 Shuangshan Road, Boshan District, Zibo, CN-SD 255000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121992

PMA Number

N/A

All Registered Proprietary Names

Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs Patient Nitrile Examination Gloves, Powder Free, Non-Sterile Patient Nitrile Examination Gloves, Powder Free, Non-Sterile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-04-07
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-04-07
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2026-04-07
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-04-07
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-01-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-03-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-09-11

Official Correspondent

MAX LI

US Agent Details

Max lee Business: BASIC MEDICAL TECHNOLOGY INC. Email: maxli@basicmedical.com Phone: (909) 9801678

Related Public Records

Same Entity

Xinwei (Shandong) Plastic and Rubber 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
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

Similar Registrations

Registration Number	Establishment Name	Location
3030671502	GUANGDONG VYIMED CO., LTD.	Qingyuan Guangdong, CN
3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US
3022543478	SHANDONG BLUE SAIL HEALTH TECHNOLOGY CO., LTD	Weifang Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028162329. Last updated year: 2026. Please use registration number 3028162329 when referencing this establishment in official correspondence.