510(k) Report

FDA applicant

American Threshold Industries, Inc.

Enka, NC20 decisions1980–19971 recall

FDA records 20 decisions for American Threshold Industries, Inc. (Enka, NC) from 1980 to 1997: 20 510(k) clearances. Most are in product codes FYC (Gown, Isolation, Surgical) and FYF (Cap, Surgical). 1 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 American Threshold Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Threshold Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Threshold Industries, 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, Surgical4decisions
  • FYFCap, Surgical2decisions
  • KMEBedding, Disposable, Medical2decisions
  • FRGWrap, Sterilization2decisions
  • KKXDrape, Surgical, Antimicrobial2decisions
  • LDQUnnamed device1decision

Also: HAX (1), FXX (1), NAB (1), FMW (1), FXP (1), HOY (1).

Who builds on its devices?

Later devices cite its devices 5 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.

  • K801036Surgical MaskAmerican Threshold Industries, Inc. · 19802cite it
  • K952116Cover GownAmerican Threshold Industries, Inc. · 19951cites it
  • K952115Barrier Gown, Kool-Gard Backless GownAmerican Threshold Industries, Inc. · 19951cites it
  • K830473Nova GauzeAmerican Threshold Industries, Inc. · 19831cites it

What has FDA decided for it lately?

  • K971483Secure-Wrap (TM) Sterilization WrapAmerican Threshold Industries, Inc. · 1997
  • K953879Surgeon's CapAmerican Threshold Industries, Inc. · 1996
  • K953878Bouffant CapAmerican Threshold Industries, Inc. · 1996
  • K952115Barrier Gown, Kool-Gard Backless GownAmerican Threshold Industries, Inc. · 1995
  • K952114Kool Gard Singles GownAmerican Threshold Industries, Inc. · 1995
  • K952116Cover GownAmerican Threshold Industries, Inc. · 1995
  • K934085Modification of Surgical Eyeshield MaskAmerican Threshold Industries, Inc. · 1993
  • K915530Nova Gauze (R) Disposable Nonwoven Sponges, SterileAmerican Threshold Industries, Inc. · 1992

All 20 as American Threshold Industries, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K801036Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental…Jun 3, 2003