Home / 510(k) Clearances / K140330

510(k) K140330

3M STERI-DRAPE FABRIC SURGICAL DRAPES by 3M Healthcare — Product Code KKX

K140330 is an FDA 510(k) premarket notification submitted by 3M Healthcare for the device "3M STERI-DRAPE FABRIC SURGICAL DRAPES". The FDA issued a decision of Substantially Equivalent on August 18, 2014. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. 3M Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2014
Date Received
February 10, 2014
Clearance Type
Traditional
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 3M Healthcare

  • K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (March 13, 2020)
  • K191355 — 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Ma (September 11, 2019)
  • K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face S (July 31, 2018)
  • K180404 — 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System (March 16, 2018)
  • K171116 — 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/18 (August 10, 2017)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K140250 — 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (July 25, 2014)
  • K974445 — 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 (July 26, 1998)
  • K980732 — 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT (May 15, 1998)
  • K974553 — 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (February 3, 1998)

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)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)
  • K140250 — 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (July 25, 2014)

FDA data resources