SHANDONG HENGYA PACKAGING PRINTING CO.,LTD

FDA Device Registration & Listing · Weifang Shandong, CN · Registration 3015412466

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
3015412466
FEI Number
3015412466
Entity Name
SHANDONG HENGYA PACKAGING PRINTING CO.,LTD
City/State/Country
Weifang Shandong, CN
Establishment Address
Hetou village, Yingqiu town, Changle county,, Weifang Shandong 262416, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shandong Hengya Packaging Printing Co.,Ltd (Owner Number: 10060268)
Owner / Operator Contact Address
Hetou village, Yingqiu town, Changle county,, Weifang, CN-SD 262416, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182640
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
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-09-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-09-17
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-09-17
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-09-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-08-16
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2024-07-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2019-04-17

Official Correspondent

Sunny Hu

US Agent Details

Renee Rees Business: Omni International Corp Email: rrees@omnigloves.com Phone: (603) 4171499

Related Public Records

Same Entity

Shandong Hengya Packaging Printing 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 3015412466. Last updated year: 2026. Please use registration number 3015412466 when referencing this establishment in official correspondence.
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