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510(k) K791719

BARRIER & FACE MASK WITH INNER FACING by Surgikos, Inc. — Product Code KKX

K791719 is an FDA 510(k) premarket notification submitted by Surgikos, Inc. for the device "BARRIER & FACE MASK WITH INNER FACING". The FDA issued a decision of Substantially Equivalent on October 4, 1979. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Surgikos, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1979
Date Received
August 30, 1979
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 Surgikos, Inc.

  • K875107 — HEALTH CARE EYE PROTECTION (March 21, 1988)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K861441 — NEUTRALON SURGICAL GLOVES (May 30, 1986)
  • K852870 — BARRIER SURGICAL GOWN (July 23, 1985)
  • K822535 — CIDEX*DIALYZER DISINFECTING SOLUTION (September 30, 1982)
  • K820543 — BARRIER ANTIMICROBIAL INCISE DRAPE (July 22, 1982)
  • K820542 — SURGIKOS INCISE DRAPE (June 2, 1982)
  • K811871 — BACTERICIDAL INCISE DRAPE (August 20, 1981)
  • K810316 — SURGIKOS FACE MASK (February 23, 1981)
  • K801864 — BARRIER APERTURED DRAPE (August 20, 1980)

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