Data / Medical devices / United States / Maxter Healthcare Inc
Maxter Healthcare Inc: FDA-registered device maker in Rosharon, TX, United States, 7 510(k) clearances
Maxter Healthcare Inc is registered with the FDA (registration 3033715710) in Rosharon, TX, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 9, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3033715710
- Address
- 14559 County Rd 48, Rosharon, TX, United States, 77583
- Owner or operator
- Maxter Healthcare Inc (10091498)
- Roles
- Manufacturer
- First device listed
- October 9, 2024
- Registered through
- 2027
- Brand names listed
- Anthem, Cashmere Non -Sterile Powder free Nitrile exam gloves- Blue, Cashmere Non -Sterile Powder free Nitrile exam gloves- Violet, Cashmere Non -Sterile Powder free Nitrile exam gloves- White, Elevate Blu, Maxter, Maxter Black, Maxter Blue and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 9, 2026 | K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | LZA | Substantially Equivalent | Maxter Healthcare, Inc. | accessdata.fda.gov |
| May 2, 2016 | K151390 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs | LZC | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| March 16, 2005 | K050530 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) | LZA | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
| August 27, 2004 | K042101 | CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Seal Polymer Industries Bhd. | accessdata.fda.gov |
| August 19, 2003 | K032077 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) | LZA | Substantially Equivalent | Seal Polymer Industries Bhd. | accessdata.fda.gov |
| April 22, 2002 | K020868 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) | LZA | Substantially Equivalent | Seal Polymer Industries Bhd. | accessdata.fda.gov |
| November 17, 1999 | K993134 | CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) | LZA | Substantially Equivalent | Seal Polymer Industries Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated September 9, 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.