Data / Medical devices / China / Bandex Industrial Corp.

Bandex Industrial Corp.: FDA-registered device maker in Zhuhai City Guangdong, China, 1 510(k) clearance

Name: Bandex Industrial Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bandex Industrial Corp. is registered with the FDA (registration 3007327603) in Zhuhai City Guangdong, China. It lists 14 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 25, 2017. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Bandex Industrial Corp.

FDA registration number: 3007327603
Address: No.1, Chuangye West Road, Shuanglinpianqu Liangang Industrial Park, Jinwan District, Zhuhai City Guangdong, China, 519045
Owner or operator: Bandex Industrial Corp. (10027300)
Roles: Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
First device listed: October 22, 2008
Registered through: 2026
Brand names listed: BANDAGE, ELASTIC, Cotton applicators, Dressing, wound, occlusive, Face mask per enforcement policy for face masks and respirators during the declared public health emergency, Gauze / sponge,nonresorbable for external use, Nitrile Gloves, Nitrile Gloves, Scissors, PAD, EYE and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Exporter to the US, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Pad, Eye	HMP	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Pick, Massaging	JET	1	Contract manufacturer, Foreign private label distributor, Manufacturer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Contract manufacturer, Foreign private label distributor, Manufacturer	accessdata.fda.gov
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	NOB	1	Contract manufacturer, Foreign private label distributor, Manufacturer	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
August 25, 2017	K170136	Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs	LZA	Substantially Equivalent	Shandong Feiyang Professional Gloves Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 25, 2017. 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.