A Plus International, Inc
Chino, CA, US
A PLUS INTERNATIONAL, INC appears in FDA device records in Chino, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for A Plus International, Inc between 1988 and 2022. The busiest year on record is 1988, with 7. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 7 |
| 2003 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213001 | Procedure Mask, Surgical Mask | FXX | Substantially Equivalent | |
| K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) | KKX | Substantially Equivalent | |
| K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | FYA | Substantially Equivalent | |
| K031353 | SOLUTION FACE MASKS | FXX | Substantially Equivalent | |
| K882284 | SURGEONS CAP | FYF | Substantially Equivalent | |
| K882283 | BOUFFANT CAP | FYF | Substantially Equivalent | |
| K882282 | SUIT, SURGICAL | FXO | Substantially Equivalent | |
| K882281 | GOWN, ISOLATION, SURGICAL (FYC) | FYC | Substantially Equivalent | |
| K882280 | COVER, SHOE OPERATING ROOM | FXP | Substantially Equivalent | |
| K881396 | OPERATING ROOM TOWELS -STERILE & NON-STERILE | KKX | Substantially Equivalent | |
| K881395 | GAUZE AND LAP SPONGES -STERILE & NON-STERILE | EFQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2083545 | 2083545 | A PLUS INTERNATIONAL, INC | 5138 EUCALYPTUS AVE., CHINO, CA 91710 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FYFCap, Surgical
- FXPCover, Shoe, Operating-Room
- KKXDrape, Surgical, Antimicrobial
- FRLFiber, Medical, Absorbent
- NABGauze / Sponge,Nonresorbable For External Use
- EFQGauze/Sponge, Internal
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FYCGown, Isolation, Surgical
- FYAGown, Surgical
- FXXMask, Surgical
- FXOSuit, Surgical
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain