510(k) K023425

DRAPES WITH ABSORBENT REINFORCEMENT by Allegiance Healthcare Corp. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 6, 2002
Date Received: October 11, 2002
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Drape, Surgical, Antimicrobial
Device Class: Class II
Regulation Number: 878.4370
Review Panel: HO
Submission Type

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

Other clearances by Allegiance Healthcare Corp.

K023673 — AIRLIFE DEMAND NASAL CANNULA (May 2, 2003)
K023419 — TRILAMINATE DRAPES/TIBURON (February 11, 2003)
K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES (January 15, 2003)
K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN (January 9, 2003)
K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (December 18, 2002)
K022765 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 11, 2002)
K023170 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 9, 2002)
K023167 — BREATHABLE SURGICAL GOWN (October 2, 2002)
K012931 — GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM (August 20, 2002)
K020818 — POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS (July 5, 2002)

Other clearances for product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
K200238 — ControlRad Sterile Cover (April 26, 2020)
K163556 — MediClear PreOp (September 14, 2017)
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
K140195 — SURGICAL DRAPE (September 10, 2014)
K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)