ALCATRON GLOVES FACTORY

FDA Device Registration & Listing · Weifang Shandong, CN · Registration 3009496643

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
3009496643
FEI Number
3009496643
Entity Name
ALCATRON GLOVES FACTORY
City/State/Country
Weifang Shandong, CN
Establishment Address
Lot 10, Xingan Road East, Linqu, Weifang Shandong 262600, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ALCATRON GLOVES FACTORY (Owner Number: 10038885)
Owner / Operator Contact Address
Lot 10, Xing'an Road East, Linqu, Weifang, CN-SD 262600, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212998
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
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2023-10-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-10-24
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-04-02
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-04-02
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-04-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-04-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-02-19

Official Correspondent

Yanmei Wang

US Agent Details

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

Related Public Records

Same Entity

ALCATRON GLOVES 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
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

Registration Number Establishment Name Location
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 3009496643. Last updated year: 2026. Please use registration number 3009496643 when referencing this establishment in official correspondence.
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