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510(k) K051625

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

K051625 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care, Inc. for the device "BARRIER SURGICAL DRAPES". The FDA issued a decision of Substantially Equivalent on July 14, 2005. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Molnlycke Health Care, Inc. has at least 10 other 510(k) clearances on record.

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)

FDA data resources