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510(k) K012807

MODIFICATION TO: COMPEL SURGICAL DRAPES by Standard Textile Co., Inc. — Product Code KKX

K012807 is an FDA 510(k) premarket notification submitted by Standard Textile Co., Inc. for the device "MODIFICATION TO: COMPEL SURGICAL DRAPES". The FDA issued a decision of Substantially Equivalent on October 11, 2001. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Standard Textile Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2001
Date Received
August 22, 2001
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 Standard Textile Co., Inc.

  • K241214 — ProPel SG3™ Surgical Gown (September 10, 2024)
  • K172207 — Standard Supreme Sterilization Wrapper (August 25, 2017)
  • K162162 — Barrier Supreme Sterilization Wrapper (November 4, 2016)
  • K060181 — COMPE1 1 -PLY SURGICAL GOWNS (March 7, 2006)
  • K041653 — COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS (July 1, 2005)
  • K041540 — COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS (May 5, 2005)
  • K041539 — COMPEL SURGICAL GOWNS (April 28, 2005)
  • K041541 — COMPEL MLR SURGICAL GOWNS (March 16, 2005)
  • K012268 — TRIMAX (December 3, 2001)
  • K010799 — COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) (June 7, 2001)

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