Data / Medical devices / China / Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.

Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.: FDA-registered device maker in shenzhen Guangdong, China, 1 510(k) clearance

Name: Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. is registered with the FDA (registration 3031590640) in shenzhen Guangdong, China. It lists 21 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 7, 2022. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.

FDA registration number: 3031590640
Address: Building 302, Kampar Chuang Industrial Park, Building 9A, Xinsha wuxiang biling community, Biling Street, Pingshan District, shenzhen Guangdong, China, 518118
Owner or operator: Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd (10090805)
Roles: Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: May 16, 2024
Registered through: 2026
Brand names listed: ANTIGEN ,RESPIRATORY SYNCYTIAL VIRUS, Anti-Parainfluenza Viruses test kit, BsAg Test Serip( Serum/Plasma/WholeBlood), DISPOSABLE NITRILE EXAMINATION GLOVES, DISPOSABLE VINYL/NITRILE BLEND GLOVES, Disposable PE Gloves, Disposable atomizer (handheld), Disposable nitrile glovcs;Disposablelatex gloves; Disposable PVC gloves; Disposable mixed Ding gloves and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	GQG	1	Manufacturer	accessdata.fda.gov
Antigens, Cf (Including Cf Control), Adenovirus 1-33	GOD	1	Manufacturer	accessdata.fda.gov
Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	GQS	1	Manufacturer	accessdata.fda.gov
Antigens, Cf, All, Mycoplasma Spp.	GSB	1	Manufacturer	accessdata.fda.gov
Antisera, Hai, Influenza Virus A, B, C	GNS	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Manufacturer	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Kit, Serological, Negative Control	MJY	1	Manufacturer	accessdata.fda.gov
Kit, Serological, Positive Control	MJX	1	Manufacturer	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	1	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Personal Protection Kit	PXC	1	Manufacturer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Exporter to the US, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 7, 2022	K222714	Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs	LZA	Substantially Equivalent	Guangdong Kingfa Sci. & Tech.Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 7, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.