Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3045062172

FEI Number

3045062172

Entity Name

GUANGDONG KINGFA MEDICAL SCI.&TECH. CO., LTD.

City/State/Country

Qingyuan Guangdong, CN

Establishment Address

NO. 36 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China, Qingyuan Guangdong 511500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGDONG KINGFA MEDICAL SCI.&TECH. CO., LTD. (Owner Number: 10095756)

Owner / Operator Contact Address

NO. 36 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China, Qingyuan, CN-GD 511500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231155

PMA Number

N/A

All Registered Proprietary Names

Biodegradable Powder Free Nitrile Examination Gloves : BIO-G02 Biodegradable Powder Free Nitrile Examination Gloves : BIO-G01 Biodegradable Powder Free Nitrile Examination Gloves : BIO-G05 Medical surgical mask (model: KF-B P05) Medical surgical mask (model: KF-B P05(L3)) colors: blue, pink, purple, white Medical Protective Mask (model: KF-A F02(N)) Medical Surgical Mask : KF-B P06 Medical Surgical Mask : KF-B P06(L3) Biodegradable Medical surgical mask:SPROUT-P11E(L1)

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	2026-04-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-04-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-04-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-04-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-04-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-04-24

Official Correspondent

Yanjun Lin

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

GUANGDONG KINGFA MEDICAL SCI.&TECH. 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
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 3045062172. Last updated year: 2026. Please use registration number 3045062172 when referencing this establishment in official correspondence.