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Cambridge Sensors USA, LLC.: FDA-registered device maker in Plainfield, IL, United States, 13 510(k) clearances

Name: Cambridge Sensors USA, LLC. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cambridge Sensors USA, LLC. is registered with the FDA (registration 3008700497) in Plainfield, IL, United States. It lists 10 device types. The FDA files 13 510(k) clearances under its listings, the newest dated December 4, 2022. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3008700497
Address: 23866 W Industrial Dr N, Plainfield, IL, United States, 60585
Owner or operator: Cambridge Sensors USA, LLC. (10042320)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: November 14, 2012
Registered through: 2027
Brand names listed: Black Nitrile Powder Free Glove (Large), Black Nitrile Powder Free Glove (Medium), Black Nitrile Powder Free Glove (Small), Black Nitrile Powder Free Glove (X-Large), Black Nitrile Powder Free Glove (XX-Large), Nitrile Examination Gloves - small, Nitrile Examination gloves - Large, Nitrile Examination gloves - medium and more

Devices it lists

Device	Product code	Class	Role	Source
Fentanyl And Other Opioid Protection Glove	QDO	1	Repackager or relabeler	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Repackager or relabeler	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Repackager or relabeler	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Complaint file establishment, 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
December 4, 2022	K222815	Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl	LZA	Substantially Equivalent	Zibo Lanhua Medical Packaging Material Co., Ltd.	accessdata.fda.gov
October 18, 2022	K222298	Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid	LZA	Substantially Equivalent	Onetexx Sdn Bhd	accessdata.fda.gov
October 3, 2022	K222376	Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)	FMK	Substantially Equivalent	Shandong Lianfa Medical Plastic Products Co. , Ltd.	accessdata.fda.gov
September 24, 2022	K222294	Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid	LZA	Substantially Equivalent	Onetexx Sdn Bhd	accessdata.fda.gov
February 17, 2022	K210864	Safety Pen Needle	FMI	Substantially Equivalent	Sandstone Medical (Suzhou), Inc.	accessdata.fda.gov
August 5, 2020	K201530	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)	LZA	Substantially Equivalent	Hartalega NGC Sdn. Bhd.	accessdata.fda.gov
March 22, 2019	K182554	Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs	LZA	Substantially Equivalent	He Chuang Plastic & Rubber Co., Ltd.	accessdata.fda.gov
December 23, 2016	K161299	BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System	NBW	Substantially Equivalent	Apex BioTechnology Corp.	accessdata.fda.gov
October 5, 2016	K161560	Fingertip Pulse Oximeter MD300CN310	DQA	Substantially Equivalent	Beijing Choice Electronic Technology Co., Ltd.	accessdata.fda.gov
November 19, 2009	K083273	MICRODOT XTRA	NBW	Substantially Equivalent	Cambridge Sensors Limited	accessdata.fda.gov
November 10, 2008	K082641	FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL	DQA	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov
June 22, 2007	K070524	MICRODOT BLOOD GLUCOSE MONITORING SYSTEM	NBW	Substantially Equivalent	Cambridge Sensors Limited	accessdata.fda.gov
September 30, 2003	K032076	SENOVA(R) BLOOD GLUCOSE MONITOR	LFR	Substantially Equivalent	Chdiagnostics, LLC	accessdata.fda.gov

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Updated December 4, 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.