Data / Medical devices / United States / K2 Health Products
K2 Health Products: FDA-registered device maker in Brooklyn, NY, United States, 16 510(k) clearances
K2 Health Products is registered with the FDA (registration 3007220726) in Brooklyn, NY, United States. It lists 10 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 11, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007220726
- Address
- 5377 Kings Hwy, Brooklyn, NY, United States, 11203
- Owner or operator
- K2 Health Products (10027056)
- Roles
- Specification developer
- First device listed
- December 15, 2010
- Registered through
- 2026
- Brand names listed
- Inspire, kolbs
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Specification developer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Specification developer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Specification developer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Specification developer | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Specification developer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Specification developer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Specification developer | 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 11, 2023 | K231439 | Powder Free White, Black, and Purple Nitrile Examination Glove | LZA | Substantially Equivalent | S&S Glove Corporation | accessdata.fda.gov |
| February 6, 2023 | K223444 | Powder Free Blue Nitrile Examination Glove | LZA | Substantially Equivalent | S&S Glove Corporation | accessdata.fda.gov |
| February 19, 2022 | K212998 | Powder Free Nitrile Examination Gloves (White, Blue and Black) | LZA | Substantially Equivalent | Alcatron Gloves Factory | accessdata.fda.gov |
| January 6, 2022 | K212847 | Penta Glove | LZA | Substantially Equivalent | Pentavest Holdings Sdn Bhd | accessdata.fda.gov |
| June 24, 2021 | K201428 | Powder Free Black Nitrile Examination Glove | LZA | Substantially Equivalent | Vietglove Corporation | accessdata.fda.gov |
| December 31, 2019 | K192444 | mCare® Powder Free Nitrile Black Examination Glove | LZA | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
| April 12, 2019 | K182640 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | LZA | Substantially Equivalent | Shandong Hengya Packaging Printing Co.,Ltd | accessdata.fda.gov |
| April 13, 2018 | K172930 | mCare Powder-free Blue Nitrile Examination Gloves | LZA | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
| May 9, 2017 | K170393 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) | LZA | Substantially Equivalent | Zibo Chengxun Automatic Device Co., Ltd. | accessdata.fda.gov |
| April 1, 2016 | K153562 | Powder Free Blue Nitrile Examination Glove | LZA | Substantially Equivalent | Vietglove Corporation | accessdata.fda.gov |
| June 17, 2013 | K123590 | VINYL EXAMINATION POWDER FREE GLOVES, CLEAR | LYZ | Substantially Equivalent | Weilin Plastic and Rubber Products Co., Ltd. | accessdata.fda.gov |
| May 8, 2012 | K112266 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR | LYZ | Substantially Equivalent | Shandong Zhiyuan Medical Products Co., Ltd. | accessdata.fda.gov |
| July 6, 2011 | K111012 | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) | LYZ | Substantially Equivalent | True Glove Factory | accessdata.fda.gov |
| May 18, 2009 | K090520 | STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE) | LYZ | Substantially Equivalent | Shandong Huayue Glove Co., Ltd. | accessdata.fda.gov |
| May 8, 2009 | K090513 | VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) | LYZ | Substantially Equivalent | Shandong Huayue Glove Co., Ltd. | accessdata.fda.gov |
| February 8, 2008 | K072228 | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) | LYZ | Substantially Equivalent | Pinnacle Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Garment, Protective, For Incontinence
- All makers of Vinyl Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Cover, Mattress (Medical Purposes)
- All makers of Dressing, Wound, Hydrophilic
- All makers of Cushion, Flotation
Updated August 11, 2023. 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.