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Poly-Lined Towel/Drape Line

by Excel Health Care Products 510(k)

Active United States

510(k) K850199

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK850199 Date21 Feb 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1240-2020 FDA Class II initiated 20 Dec 2019

    Product lidstock contains the incorrect expiration date for the product

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, 19 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 Poly-Lined Towel/Drape Line is a surgical accessory designed to support and organize towels and drapes during operative procedures. It consists of a poly‑lined material that provides a clean, durable surface for handling sterile linens in the operating room.

The device was cleared by the FDA through a traditional 510(k) submission (K850199) and is classified as a class II device (product code KKX) for general and plastic surgery applications. It is supplied by Excel Health Care Products and is intended for use in accordance with the FDA clearance specifications.

Other devices from Excel Health Care Products

Questions

AI-generated answers, 19 Sep 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 Poly-Lined Towel/Drape Line specifically designed to do in the operating room?

    The Poly-Lined Towel/Drape Line is designed to support and organize towels and drapes during surgical procedures. Its poly-lined material provides a clean, durable surface that helps maintain sterility while handling linens, reducing the risk of contamination and improving workflow efficiency.

  • How is this device supplied, and is it intended for single-use or reuse?

    The Poly-Lined Towel/Drape Line is supplied by Excel Health Care Products as a reusable surgical accessory. While the exact reuse guidelines would depend on facility protocols, its durable poly-lined material suggests it is engineered for repeated use in sterile environments, provided proper cleaning and maintenance are followed.

  • What types of surgical procedures is this device cleared for, and how does that relate to its classification?

    This device is cleared for use in general and plastic surgery applications, as indicated by its FDA 510(k) clearance (K850199) under product code KKX. The classification as a Class II device reflects its moderate risk level, requiring special controls beyond general controls to ensure safety and effectiveness in these surgical contexts.

  • Is the Poly-Lined Towel/Drape Line sterile upon receipt, and if not, how should it be prepared for use?

    The provided data does not explicitly state whether the device is sterile upon receipt, but given its reusable design and operating room use, it would typically require sterilization before first use and between uses. Facilities should follow established protocols for cleaning, disinfection, or sterilization (e.g., autoclave or chemical sterilization) to ensure sterility before use in surgical procedures.