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510(k) K970891

DRAPE, SURGICAL-LATEX by Protek Medical Products, Inc. — Product Code KKX

K970891 is an FDA 510(k) premarket notification submitted by Protek Medical Products, Inc. for the device "DRAPE, SURGICAL-LATEX". The FDA issued a decision of Substantially Equivalent on August 22, 1997. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Protek Medical Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1997
Date Received
March 11, 1997
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 Protek Medical Products, Inc.

  • K973958 — GENERAL PURPOSE ATL NEEDLE GUIDE KIT (January 22, 1998)
  • K973622 — TRANSDUCER POSITIONER (November 26, 1997)
  • K970889 — ULTRASOUND TRANSDUCER DRAPE (October 20, 1997)
  • K970893 — ULTRASOUND TRANSDUCER DRAPE (October 20, 1997)
  • K973362 — NEEDLE GUIDE/GRID (October 1, 1997)
  • K970885 — ULTRASOUND SYSTEMS DRAPE (September 22, 1997)
  • K971722 — TRANS VAGINAL NEEDLE GUIDE (July 10, 1997)
  • K971115 — GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE (June 13, 1997)

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