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Patient Drape, Surgical

by Advance Medical Designs, Inc.

510(k) K003670

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K003670↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK003670 Date26 Jan 2001ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 Sep 2026

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

The Patient Drape, Surgical is a sterile barrier device classified as a surgical drape under the nomenclature for protective apparel. It is designed to maintain a sterile field during surgical procedures by isolating the patient and protecting the incision site from contamination.

This device is supplied as a single-use item, intended for use in operating room settings. It is authorised under FDA 510K clearance and MDR compliance, ensuring adherence to regulatory standards for surgical drapes. The product is packaged in sterile form and must be stored according to manufacturer guidelines to preserve sterility and integrity.

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Questions

AI-generated answers, 18 Sep 2026

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

  • Is this surgical drape reusable or intended for single-use only, and why does that matter in an operating room setting?

    This surgical drape is explicitly designed for single-use only, as stated in the device description. Single-use ensures sterility is maintained for each patient, reducing the risk of cross-contamination between procedures. Reusing a drape could compromise its barrier integrity and introduce pathogens, which is critical in sterile operating room environments where infection control is paramount.

  • How should I store this drape to keep it sterile and intact until use, according to the manufacturer’s guidelines?

    The device must be stored in its original sterile packaging to preserve sterility and integrity. Exposure to moisture, heat, or physical damage can compromise the drape’s protective properties. Always follow the manufacturer’s storage instructions—typically, this means keeping it in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.

  • What regulatory pathways does this drape follow, and what does that mean for its use in clinical settings?

    This drape is authorized under FDA 510(k) clearance and MDR compliance, meaning it has undergone regulatory review to demonstrate equivalence to legally marketed devices and adherence to EU medical device regulations. Clinically, this ensures it meets safety and performance standards for surgical use, though actual use remains governed by facility protocols and surgeon discretion.

  • Are there different sizes or models available for this drape, and if so, how would I know which one to select for a patient?

    The provided specifications do not list specific sizes or models, so the device description implies a standardized design for general surgical use. Selection would depend on the procedure’s scope and patient anatomy, but you’d need to consult the manufacturer’s catalog or packaging for exact dimensions or variations. Always verify compatibility with your facility’s surgical needs before use.