SHIELD LUCKY CAP - Shield Lucky Cap

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K800511 ↗

FDA Product Code

FYF

Models / Variants

Shield Lucky Cap

Blossom Bouffant Cap

Device Class

Class I

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Tomac Sterile Disp. Lap Sponge

  Class I

  FDA 510(k) K812554 Active Cleared 24 Sep 1981

• Antimicrobial Incise Drape

  Class II

  FDA 510(k) K840957 Active Cleared 7 Jun 1984

• Disimetric Release of Instranetics Rad

  Class I

  FDA 510(k) K830786 Active Cleared 18 May 1983

• Tackmer Incise Drape

  Class II

  FDA 510(k) K802050 Active Cleared 16 Sep 1980

• Convertors Sterile Disp. Lap Sponge II

  Unclassified

  FDA 510(k) K813296 Active Cleared 29 Dec 1981

• Disp. Fenestrated Surg. Drape Sheets

  Class II

  FDA 510(k) K802359 Active Cleared 31 Oct 1980

See all devices from American Convertors Div., American Pharmaseal →