Data / Medical devices / United States / Uline, Inc.
Uline, Inc.: FDA-registered device maker in Pleasant Prairie, WI, United States, 28 510(k) clearances
Uline, Inc. is registered with the FDA (registration 3002661124) in Pleasant Prairie, WI, United States. It lists 13 device types. The FDA files 28 510(k) clearances under its listings, the newest dated May 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3002661124
- Address
- 12575 Uline Dr, Pleasant Prairie, WI, United States, 53158
- Owner or operator
- Uline, Inc. (10026543)
- Roles
- Repackager or relabeler
- First device listed
- November 14, 2013
- Registered through
- 2026
Devices it lists
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 |
|---|---|---|---|---|---|---|
| May 15, 2023 | K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | LZA | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| March 4, 2022 | K210330 | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| January 9, 2022 | K211666 | Powder Free Nitrile Examination Gloves, Blue Chemotest | LZA | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| March 20, 2020 | K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| June 20, 2019 | K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| January 24, 2019 | K182514 | Surgical Face Mask | FXX | Substantially Equivalent | Xiantao Zhibo Non-Woven Products Co., Ltd. | accessdata.fda.gov |
| November 20, 2018 | K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Kossan International Sdn Bhd | 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 |
| February 25, 2016 | K152593 | LATEX EXAMINATION GLOVE POWDER FREE | LYY | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| July 24, 2014 | K140890 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| April 8, 2014 | K133949 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Top Calibre Sdn Bhd | accessdata.fda.gov |
| December 13, 2013 | K132484 | DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| July 17, 2013 | K123787 | GREENCROSS SURGICAL MASK | FXX | Substantially Equivalent | Jingzhou Haixin Green Cross Medical Products Co.,L | accessdata.fda.gov |
| March 5, 2013 | K123819 | MULTIPLE NAME | LYY | Substantially Equivalent | Top Calibre Sdn Bhd | accessdata.fda.gov |
| May 14, 2012 | K120692 | LATEX EXAMINATION GLOVES (POWDER FREE) | LYY | Substantially Equivalent | Top Calibre Sdn Bhd | accessdata.fda.gov |
| October 19, 2009 | K092034 | POWDER FREE NITRILE EXAMINATION GLOVES, BLACK | LZA | Substantially Equivalent | Pt. Smartglove Indonesia | accessdata.fda.gov |
| October 2, 2009 | K090568 | MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN | LZA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| May 23, 2008 | K080937 | POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| March 14, 2007 | K070096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| April 27, 2006 | K060753 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| June 6, 2002 | K021220 | NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| May 15, 2000 | K001280 | COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES | LYY | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| November 30, 1998 | K982877 | MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE | LYY | Substantially Equivalent | Matang Mfg. Sdn. Bhd. | accessdata.fda.gov |
| May 6, 1997 | K970794 | LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| October 11, 1996 | K953213 | COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| July 26, 1996 | K962188 | COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| June 27, 1996 | K953590 | COMFIT | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| December 15, 1995 | K952051 | SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) | LZA | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Protector, Hearing (Circumaural)
- All makers of Accessory, Surgical Apparel
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
Updated May 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.