Data / Medical devices / United States / American Healthcare Products, Inc.
American Healthcare Products, Inc.: FDA-registered device maker in Alhambra, CA, United States, 2 510(k) clearances
American Healthcare Products, Inc. is registered with the FDA (registration 2084709) in Alhambra, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 4, 1999. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2084709
- FEI number
- 1000099913
- Address
- 1028 Westminster Ave., Alhambra, CA, United States, 91803
- Owner or operator
- AMERICAN HEALTHCARE PRODUCTS, INC. (9004110)
- Roles
- Specification developer
- First device listed
- April 7, 2016
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 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 |
|---|---|---|---|---|---|---|
| February 4, 1999 | K983614 | UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED) | LYY | Substantially Equivalent | American Healthcare Products (M) Sdn Bhd | accessdata.fda.gov |
| November 30, 1998 | K982218 | NITRILE POWDER-FREE UNISEAL GLOVES | LZA | Substantially Equivalent | American Healthcare Products (M) Sdn Bhd | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 23, 2002 | 25611 | Not yet classified | Terminated | Latex examination gloves, Uniseal brand. | Unfit for intended use due to stickiness. | accessdata.fda.gov |
Compare with other makers
Updated March 12, 2003. 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.