Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015537296

FEI Number

3015537296

Entity Name

HEBEI ASTRO MEDICAL SUPPLY CO.,LTD

City/State/Country

Jinzhou city Hebei, CN

Establishment Address

East of xiaoxixian,west of jingsan street,south of weiwu road,north of weiqi road, economic development zone, Jinzhou city Hebei 052260, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hebei Astro Medical Supply Co.,Ltd (Owner Number: 10062021)

Owner / Operator Contact Address

East of xiaoxixian,west of jingsan street,south of weiwu road,north of weiqi road, economic development zone, Jinzhou city, CN-HE 052260, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213019

PMA Number

N/A

All Registered Proprietary Names

Nitrile Exam gloves Vinyl Exam gloves

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	2022-09-01
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2022-09-01

Official Correspondent

Guo Huanqiang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Hebei Astro Medical Supply 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

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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 3015537296. Last updated year: 2026. Please use registration number 3015537296 when referencing this establishment in official correspondence.