Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009218271

FEI Number

3009218271

Entity Name

ZIBO SHENGKUN CHEMICAL INDUSTRY CO LTD

City/State/Country

Zibo Shandong, CN

Establishment Address

Lot 6, No. 21 Qingtian Road, Qilu Chemical Industrial Park, Zibo Shandong 255414, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ZIBO SHENGKUN CHEMICAL INDUSTRY CO LTD (Owner Number: 10038385)

Owner / Operator Contact Address

Lot 6, No. 21 Qingtian Road, Qilu Chemical Industrial, Zibo, CN-SD 255414, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Multiple Brand Customer's private label

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	2025-07-08
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2011-10-10
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2024-08-13
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2024-08-22

Official Correspondent

Ming Miao

US Agent Details

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

Related Public Records

Same Entity

ZIBO SHENGKUN CHEMICAL INDUSTRY 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

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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 3009218271. Last updated year: 2026. Please use registration number 3009218271 when referencing this establishment in official correspondence.