Data / Medical devices / Polymer Patient Examination Glove / United States
FDA-registered makers of Polymer Patient Examination Glove in the United States: 47 establishments
47 establishments in the United States are registered with the FDA to make Polymer Patient Examination Glove (product code LZA). 46 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Polymer Patient Examination Glove
- Product code
- LZA
- Country
- United States
Makers of Polymer Patient Examination Glove in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ansell Healthcare Products LLC | Reno, NV, United States | Manufacturer, Specification developer | 65 | August 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 51 | July 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| SW Technologies Inc. | Union City, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | 20 | June 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Mexpo International, Inc. | Union City, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 17 | February 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Haywood Vocational Opportunities Inc. | Waynesville, NC, United States | Contract manufacturer, Repackager or relabeler | 15 | February 11, 2015 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 12 | October 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| K2 Health Products | Brooklyn, NY, United States | Specification developer | 10 | August 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Labsource, Inc | Northlake, IL, United States | Specification developer | 10 | December 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Maxter Healthcare Inc | Rosharon, TX, United States | Manufacturer | 6 | September 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Prestige Ameritech | North Richland Hills, TX, United States | Complaint file establishment, Specification developer | 6 | November 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 5 | September 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| American Armor Gloves | West Columbia, SC, United States | Complaint file establishment, Manufacturer | 4 | March 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ansell Healthcare Products LLC | Iselin, NJ, United States | Manufacturer, Specification developer | 4 | October 9, 2015 | 0 | 0 | 0 | api.fda.gov |
| Bay Medical | Brisbane, CA, United States | Specification developer | 3 | April 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| D&M Procurement | Houston, TX, United States | Specification developer | 3 | July 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| GCB Medical LLC | Duxbury, MA, United States | Complaint file establishment, Specification developer | 3 | February 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ready Set Import | Beverly Hills, CA, United States | Complaint file establishment, Specification developer | 3 | June 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sna Safehealth Solutions Inc. | Monrovia, CA, United States | Complaint file establishment, Specification developer | 3 | November 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Unisafe Inc. | Bohemia, NY, United States | Specification developer | 3 | May 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ascend Eagle, Inc. | Pinole, CA, United States | Specification developer | 2 | October 15, 2010 | 0 | 0 | 0 | api.fda.gov |
| CT Intl. | San Luis Obispo, CA, United States | Specification developer | 2 | June 22, 1998 | 0 | 0 | 0 | api.fda.gov |
| Genabio Diagnostics Inc | Bedford, MA, United States | Specification developer | 2 | August 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| PM Gloves, Inc. | Chino, CA, United States | Complaint file establishment, Specification developer | 2 | June 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| TNG Worldwide Inc | New Hudson, MI, United States | Specification developer | 2 | August 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| 4 Cascade Partners, LLC | Renton, WA, United States | Manufacturer | 1 | December 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| American Healthcare Products, Inc. | Alhambra, CA, United States | Specification developer | 1 | November 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| American Nitrile Operations LLC | Grove City, OH, United States | Contract manufacturer, Manufacturer | 1 | July 8, 2022 | 0 | 1 | 0 | api.fda.gov |
| Ammex Corporation | Kent, WA, United States | Manufacturer | 1 | December 18, 2021 | 0 | 0 | 0 | api.fda.gov |
| Anrel Distribution LLC | Jackson, NJ, United States | Manufacturer | 1 | October 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| American Pride Paper & Plastic LLC. | Lakewood, NJ, United States | Manufacturer | 1 | November 18, 2005 | 0 | 0 | 0 | api.fda.gov |
| BiometerPlus USA, Inc. | Fremont, CA, United States | Repackager or relabeler, Specification developer | 1 | October 12, 2017 | 0 | 0 | 0 | api.fda.gov |
| Dynarex Corp. | Middletown, NY, United States | Specification developer | 1 | September 12, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ecomed Solutions, LLC | Lindenhurst, IL, United States | Complaint file establishment, Specification developer | 1 | April 15, 2011 | 0 | 0 | 0 | api.fda.gov |
| Gel-X LLC | Wilmington, DE, United States | Manufacturer, Specification developer | 1 | May 13, 2011 | 0 | 0 | 0 | api.fda.gov |
| Global Protection Corp. | Lynn, MA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | September 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hudson Scientific LLC | Hudson, MI, United States | Specification developer | 1 | August 3, 2016 | 0 | 0 | 0 | api.fda.gov |
| Mayer Laboratories | Berkeley, CA, United States | Repackager or relabeler, Specification developer | 1 | November 17, 1999 | 0 | 0 | 0 | api.fda.gov |
| Magicare Tech Corp | Ontario, CA, United States | Manufacturer | 1 | April 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 1 | January 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| SAS Safety Corp. | Cerritos, CA, United States | Reprocessor | 1 | May 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| SafeSource Direct Glove Plant | Broussard, LA, United States | Manufacturer | 1 | November 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ug Healthcare (usa), Inc. | Costa Mesa, CA, United States | Specification developer | 1 | March 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| Us Medical Glove Company | Harvard, IL, United States | Complaint file establishment, Manufacturer | 1 | January 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| US Paper Mill LLC | Chillicothe, OH, United States | Complaint file establishment, Manufacturer | 1 | January 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Vista Industries, LLC. | Hacienda Heights, CA, United States | Manufacturer | 1 | June 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Vital Edge Instruments LLC | Leesburg, VA, United States | Repackager or relabeler, Specification developer | 1 | February 28, 2013 | 0 | 0 | 0 | api.fda.gov |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.