Boundary Specialty Gown

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791062 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Rely Tampon

  Class II

  FDA 510(k) K761184 Active Cleared 17 Dec 1976

• Unscented Menstrual Pad

  Class I

  FDA 510(k) K834144 Active Cleared 29 Dec 1983

• Tampax Compak Pearl Plastic Applicator Scented and Unscented Tampons

  Class II

  FDA 510(k) K062638 Active Cleared 22 Nov 2006

• Always Super Maxipad-Scented

  Class II

  FDA 510(k) K850939 Active Cleared 14 May 1985

• Always Menstrual Pads

  Class I

  FDA 510(k) K071827 Active Cleared 20 Sep 2007

• Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies)

  Class II

  FDA 510(k) K040999 Active Cleared 9 Jul 2004

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