Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007220726

FEI Number

3007220726

Entity Name

K2 HEALTH PRODUCTS

City/State/Country

Brooklyn, NY, US

Establishment Address

5377 Kings Hwy, Brooklyn, NY 11203, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

K2 Health Products (Owner Number: 10027056)

Owner / Operator Contact Address

5377 kings highway, Brooklyn, NY 11203, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

kolbs Inspire Inspire Inspire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2010-12-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-10-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-10-19
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2023-10-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-03-20
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2010-12-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-03
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2011-10-10
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2010-12-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-31
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-10-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-03-20
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2024-06-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-03-20
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-03-20
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2024-09-10
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2021-07-29
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2012-11-06

Official Correspondent

Moshe Klerer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

K2 Health Products

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

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3004116007	Legs 4 Life, LLC	ASHEBORO, NC, US
3009056001	STME Acquisition LLC	Palmetto, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007220726. Last updated year: 2026. Please use registration number 3007220726 when referencing this establishment in official correspondence.