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510(k) K945755

OREX(R) O.R EQUIPMENT DRAPES by Thantex Specialties, Inc. — Product Code KKX

K945755 is an FDA 510(k) premarket notification submitted by Thantex Specialties, Inc. for the device "OREX(R) O.R EQUIPMENT DRAPES". The FDA issued a decision of Substantially Equivalent on May 25, 1995. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Thantex Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1995
Date Received
November 23, 1994
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 Thantex Specialties, Inc.

  • K970547 — ISOLYSER SDS SHARPS CONTAINER (July 18, 1997)
  • K961083 — OREX SURGEON'S VEST (August 23, 1996)
  • K942200 — ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (August 7, 1995)
  • K943626 — ISOLYSER SHARPS MANAGEMENT SYSTEM SMS (June 16, 1995)
  • K945223 — OREX ISOLATION GOWN (April 25, 1995)
  • K944859 — OREX SURGICAL DRAPES (February 28, 1995)
  • K944827 — OREX SURGEON'S GOWN (February 28, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K942228 — OREX O.R. TOWEL (December 20, 1994)
  • K940765 — ISOLYSER (December 19, 1994)

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