Data / Medical devices / United States / A Plus International, Inc
A Plus International, Inc: FDA-registered device maker in Chino, CA, United States, 3 510(k) clearances
A Plus International, Inc is registered with the FDA (registration 2083545) in Chino, CA, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 11, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2083545
- Address
- 5138 Eucalyptus Ave., Chino, CA, United States, 91710
- Owner or operator
- A PLUS INTERNATIONAL, INC (2083545)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- May 10, 1994
- Registered through
- 2026
- Brand names listed
- Procedure Mask / Surgical Mask, Ear loops and Tie-On
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fiber, Medical, Absorbent | FRL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauze/Sponge, Internal | EFQ | U | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | 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 |
|---|---|---|---|---|---|---|
| May 11, 2022 | K213001 | Procedure Mask, Surgical Mask | FXX | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| June 19, 2003 | K031353 | SOLUTION FACE MASKS | FXX | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| April 28, 1988 | K881395 | GAUZE AND LAP SPONGES -STERILE & NON-STERILE | EFQ | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Fiber, Medical, Absorbent
- All makers of Mask, Surgical
- All makers of Gauze/Sponge, Internal
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Gauze / Sponge,Nonresorbable For External Use
Updated May 11, 2022. 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.