TRUE GLOVE FACTORY

FDA Device Registration & Listing · Weifang Shandong, CN · Registration 3009055041

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009055041
FEI Number
3009055041
Entity Name
TRUE GLOVE FACTORY
City/State/Country
Weifang Shandong, CN
Establishment Address
NO.6-1 East XingAn Road, Linqu, Weifang Shandong 262600, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
TRUE GLOVE FACTORY (Owner Number: 10036844)
Owner / Operator Contact Address
NO.6-1 East Xing'an Road, Linqu, Weifang, CN-SD 262600, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182554
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-08-27
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-01-29
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2011-05-31
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-12-09
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2023-12-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-09-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-09-21

Official Correspondent

Jianbo Shi

US Agent Details

Renee Rees Business: Omni International Corp Email: rrees@omnigloves.com Phone: (603) 4711499

Related Public Records

Same Entity

TRUE GLOVE FACTORY
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
9610406 ANSELL (THAILAND) LTD. THAILAND Krung Thep Maha Nakhon, TH
3026062711 RMKH GLOVE (CAMBODIA) CO., LTD. Bavet City Svay Rieng, KH
3043739177 US Paper Mill LLC Chillicothe, OH, US
3042765418 VITAL EDGE INSTRUMENTS LLC Leesburg, VA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009055041. Last updated year: 2026. Please use registration number 3009055041 when referencing this establishment in official correspondence.
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