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Protective Shorts

by Y. Daneshvar, M.D. 510(k)

Active United States

510(k) K943948

Overview

Protective shorts are a device intended to provide a barrier against leakage and contamination. The device consists of a protective cover made from a thin layer of impermeable material, such as vinyl, aluminium, or latex, which prevents the escape of oily materials and secretions and protects the skin from contamination.

The protective shorts are supplied non-sterile and are intended for single use. They are designed for use in clinical or home settings to contain medication or secretions, particularly in the anal area, and are authorized under FDA 510(k) clearance K943948 with product code DXC.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943948 Date5 Jun 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DXC
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Y. Daneshvar

Questions

  • What are protective shorts used for?

    Protective shorts are intended to provide a barrier against leakage and contamination, specifically to contain medication or secretions and protect the skin, particularly in the anal area, during clinical or home use.

  • Are protective shorts sterile or non-sterile, and can they be reused?

    The protective shorts are supplied non-sterile and are designed for single use only; they should not be reused as this compromises the barrier integrity and increases contamination risk.

  • What materials are protective shorts made from, and how do they prevent leakage?

    Protective shorts consist of a thin layer of impermeable material such as vinyl, aluminium, or latex, which forms a barrier that prevents the escape of oily materials and secretions and protects the skin from contamination.