510(k) K051625

BARRIER SURGICAL DRAPES by Molnlycke Health Care, Inc. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 14, 2005
Date Received: June 20, 2005
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 Molnlycke Health Care, Inc.

K130852 — AVANCE® FOAM ABDOMINAL DRESSING KIT (April 14, 2014)
K130040 — MEPITEL AG (February 12, 2014)
K123892 — MEPILEX TRANSFER AG (April 5, 2013)
K122132 — AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LA (January 17, 2013)
K102923 — BARRIER N95 PARTICULATE RESPIRATOR (November 19, 2010)
K100029 — MEPILEX BORDER AG DRESSING (September 15, 2010)
K061554 — MEPILEX AG ABSORBENT SILICONE-COATED DRESSING (January 25, 2007)
K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPREN (October 5, 2006)
K050786 — BARRIER SURGICAL GOWNS (May 9, 2005)
K031131 — KLINIDRAPE SURGICAL DRAPES (June 10, 2003)

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)