510(k) Report

FDA applicant

Royal American Industries, Inc.

Boca Raton, FL2 decisions1987–19870 recalls

FDA records 2 decisions for Royal American Industries, Inc. (Boca Raton, FL) in 1987: 2 510(k) clearances. All are in product code HIS (Condom). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Royal American Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Royal American 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?

  • HISCondom2decisions

What has FDA decided for it lately?

  • K872504Lubricated CondomRoyal American Industries, Inc. · 1987
  • K874464Spermicidal CondomRoyal American Industries, Inc. · 1987

All 2 as Royal American Industries, Inc. →

Other applicant names beginning “Royal”

FDA records each applicant name separately; these may or may not be the same firm.

Royal Enterprises Manufacturing, Inc. 2Royal Oak Medical Devices 2Royal Precision Plastics, Inc. 1Royal King Infant Products Co., Ltd. 1Royal Flash Enterprise Co., Ltd. 1Royal Industries (Thailand) Public Co., Ltd. 1Royal Shine Enterprises, Ltd. 1Royal Scientific, Inc. 1Royal Dental Lab 1Royal Plastic Sarl 1Royal Pacific Intl. Trade, Inc. 1