510(k) Report

FDA applicant

Rx Textiles, Inc.

Monroe, NC1 decision1996–19961 recall

FDA records 1 decision for Rx Textiles, Inc. (Monroe, NC) in 1996: 1 510(k) clearance. All are in product code KKX (Drape, Surgical, Antimicrobial). 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 Rx Textiles, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rx Textiles, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rx Textiles, 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?

  • KKXDrape, Surgical, Antimicrobial1decision

What has FDA decided for it lately?

  • K960803RX Textiles Sterile StockinetteRx Textiles, Inc. · 19961 recall

The one decision as Rx Textiles, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K960803PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double…Jun 11, 2003