Data / Medical devices / United States / Labsource, Inc
Labsource, Inc: FDA-registered device maker in Northlake, IL, United States, 11 510(k) clearances
Labsource, Inc is registered with the FDA (registration 3012429634) in Northlake, IL, United States. It lists 5 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012429634
- Address
- 1260 Garnet Drive, Northlake, IL, United States, 60164
- Owner or operator
- Labsource, Inc (10072994)
- Roles
- Specification developer
- First device listed
- June 9, 2023
- Registered through
- 2027
- Brand names listed
- American Health And Safety Violet Blue Nitrile Exam Glove, American Health and Safety Blue Nitrile, American Health and Safety Zircon Black, American Health and Safety Zircon Blue, American Health and Safety Zircon Touch Cobalt Blue Nitrile Exam Gloves, American Health and Safety Zircon X Blue Nitrille, American Health and safety Zircon Blue, american health and safety
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Specification developer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 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 |
|---|---|---|---|---|---|---|
| December 15, 2023 | K233182 | Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) | LZA | Substantially Equivalent | Zibo Kaiyue Mould Technology Co., Ltd. | accessdata.fda.gov |
| February 10, 2023 | K222129 | Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | LZA | Substantially Equivalent | Top Glove Medical (Thailand) Co., Ltd. | accessdata.fda.gov |
| 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 |
| February 24, 2021 | K202003 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | LZA | Substantially Equivalent | Gmp Medicare Sdn. Bhd. | accessdata.fda.gov |
| May 28, 2019 | K190606 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| October 9, 2015 | K151528 | Powder Free Nitrile (Black) Examination Gloves | LZA | Substantially Equivalent | Gallant Quality Sdn. Bhd. | accessdata.fda.gov |
| August 6, 2010 | K101595 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Better Care Plastic Technology Cp., Ltd. | accessdata.fda.gov |
| April 28, 2006 | K060147 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Hongye Plastic Products Co., Ltd. | accessdata.fda.gov |
| September 20, 2004 | K042378 | NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE | LZA | Substantially Equivalent | Shijiazhuang Tillotson Rubber Products Co., Ltd. | accessdata.fda.gov |
| February 26, 2002 | K020493 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. | accessdata.fda.gov |
| April 23, 1998 | K974424 | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD | LYY | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated December 15, 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.