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510(k) K981823

OPERATING ROOM TOWELS by Baldur Systems Corp. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1998
Date Received
May 22, 1998
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 Baldur Systems Corp.

  • K974347 — BALDUR NON-STERILE COTTON SPONGES (February 10, 1998)
  • K892684 — PATIENT EXAMINATION GLOVES (LATEX) (September 11, 1989)
  • K891728 — LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) (May 25, 1989)
  • K891727 — LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD) (May 12, 1989)
  • K891726 — VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) (May 12, 1989)

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)