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Drapes, Modesty

by Mark One Healthcare Products

510(k) K770396

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770396 Date23 Mar 1977ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Drape, Modesty is a surgical drape designed to provide patient modesty and privacy during medical procedures. Classified as a Drape, Surgical, Antimicrobial, it is intended to maintain a sterile field while ensuring patient dignity by covering exposed areas. Constructed from plastic material, it adheres to regulatory standards for single-use medical devices in surgical settings.

Supplied as a sterile, single-use item, the drape is intended for use in general and plastic surgery procedures. It is regulated under FDA 510(k) clearance (K770396) and falls under product code KKX, with a decision of Substantially Equivalent (SESE). Storage and handling must comply with standard sterile barrier precautions to preserve integrity before use.

Other devices from Mark One Healthcare Products

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Modesty Surgical Drape designed for?

    The Modesty Surgical Drape is specifically designed to provide patient modesty and privacy during surgical procedures, particularly in general and plastic surgery settings. Its primary function is to cover exposed areas while maintaining a sterile field, ensuring both clinical safety and patient comfort.

  • Is the Modesty Surgical Drape reusable or single-use?

    The Modesty Surgical Drape is intended for single-use only. This classification aligns with regulatory standards for maintaining sterility and hygiene in surgical environments, reducing the risk of contamination between patients.

  • How should the Modesty Surgical Drape be stored?

    The drape must be stored according to standard sterile barrier precautions to preserve its integrity before use. This includes keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures.

  • What regulatory clearance does the Modesty Surgical Drape hold?

    The Modesty Surgical Drape holds FDA 510(k) clearance under the reference number K770396. It was classified as substantially equivalent (SESE) to a predicate device and falls under product code KKX, intended for use in general and plastic surgery procedures.

  • What material is the Modesty Surgical Drape made from?

    The drape is constructed from plastic material, which is designed to meet regulatory standards for single-use medical devices in surgical settings. The material ensures durability, sterility, and ease of use during procedures.