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510(k) K121919

SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV by Exact Medical Manufacturing, Inc. — Product Code KKX

K121919 is an FDA 510(k) premarket notification submitted by Exact Medical Manufacturing, Inc. for the device "SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV". The FDA issued a decision of Substantially Equivalent on February 14, 2013. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Exact Medical Manufacturing, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2013
Date Received
July 2, 2012
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 Exact Medical Manufacturing, Inc.

  • K222460 — Intraoperative Ultrasound Probe Cover (May 12, 2023)
  • K211969 — EMM Ultrasonic Transducer Cover (August 13, 2021)
  • K120045 — EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV (June 12, 2012)
  • K111535 — EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER (August 26, 2011)
  • K101598 — EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATION (October 4, 2010)
  • K101689 — EMM EQUIPMENT COVER-POLYTHYLENE (September 20, 2010)
  • K101688 — EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 (September 20, 2010)
  • K101593 — EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-5 (September 3, 2010)

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