510(k) Report

FDA applicant

Global Healthcare, Inc.

Atlanta, GA3 decisions1996–19990 recalls

FDA records 3 decisions for Global Healthcare, Inc. (Atlanta, GA) from 1996 to 1999: 3 510(k) clearances. Most are in product codes FYC (Gown, Isolation, Surgical) and FXX (Mask, Surgical). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Global Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Global Healthcare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Global Healthcare, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FYCGown, Isolation, Surgical1decision
  • FXXMask, Surgical1decision
  • FRGWrap, Sterilization1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K990567Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 19993cite it

What has FDA decided for it lately?

  • K990567Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
  • K954549Surgical ApparelGlobal Healthcare, Inc. · 1996
  • K953754Global Healthcare Face MaskGlobal Healthcare, Inc. · 1996

All 3 as Global Healthcare, Inc. →