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Drapes With Absorbent Reinforcement

by Allegiance Healthcare Corp.

510(k) K023425

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 · Special NumberK023425 Date6 Nov 2002ClearedStatusActive

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  • Withdrawn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, 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.

This device is a Surgical Drapes with Absorbent Reinforcement, classified under product code KKX. It features a base layer of nonwoven material with a laminated absorbent structure designed to provide a sterile barrier in surgical settings. The absorbent reinforcement helps manage fluids and reduce contamination risks at incision sites, enhancing patient safety during procedures.

Used in surgical environments, these drapes are intended to isolate incision areas from microbial and other contaminants. Supplied as sterile, single-use items, they require proper storage to maintain integrity. The device holds an FDA 510(k) clearance (K023425) under Special Review, ensuring compliance with regulatory standards for Class II medical devices.

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