Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008700497

FEI Number

3008700497

Entity Name

Cambridge Sensors USA, LLC.

City/State/Country

Plainfield, IL, US

Establishment Address

23866 W Industrial Dr N, Plainfield, IL 60585, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Cambridge Sensors USA, LLC. (Owner Number: 10042320)

Owner / Operator Contact Address

23866 W Industrial Drive N, Plainfield, IL 60585, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070524

PMA Number

N/A

All Registered Proprietary Names

microdot 28g Lancet microdot 26g Lancet microdot 23g 100ct Lancet microdot 21g Lancet microdot 30g Lancet microdot 23g 200ct Lancet Nitrile Powder Free Glove (X-Large) Black Nitrile Powder Free Glove (XX-Large) Black Nitrile Powder Free Glove (Small) Black Nitrile Powder Free Glove (X-Large) Black Nitrile Powder Free Glove (Medium) Nitrile Powder Free Glove (Small) Nitrile Powder Free Glove (Medium) Nitrile Powder Free Glove (XX-Large) Black Nitrile Powder Free Glove (Large) Nitrile Powder Free Glove (Large) microdot microdot Pro Nitrile Gloves XX-Large microdot Pro Nitrile Gloves Medium microdot Pro Nitrile Gloves Small microdot Pro Nitrile Gloves X-Large microdot Pro Nitrile Gloves Large microdot® Pulse Oximeter Nitrile Examination Gloves - small Nitrile Examination gloves - medium Nitrile Examination gloves - Large Nitrile Examination gloves - small microdot microdot® Flex Nitrile Gloves Medium microdot® Flex Nitrile Gloves X-Large microdot® Flex Nitrile Gloves Small microdot® Flex Nitrile Gloves Large microdot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-12-06
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-01-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-01-10
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-01-10
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-01-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-01-09
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-12-05
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-12-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-01-15
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-12-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-12-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-04-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-12-09
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-12-09
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-12-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-12-09
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-11-14
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-11-14
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-11-14

Official Correspondent

Chris Sullivan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cambridge Sensors USA, LLC.

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
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008700497. Last updated year: 2026. Please use registration number 3008700497 when referencing this establishment in official correspondence.