Home / 510(k) Clearances / K141324

510(k) K141324

HONGYU DISPOSABLE SURGICAL DRAPES by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2015
Date Received
May 20, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

  • K214088 — Disposable Surgical Gown (April 12, 2022)
  • K220133 — Sterilization Wraps (March 10, 2022)
  • K213029 — Nitrile Examination Gloves (Powder free, Blue) (December 14, 2021)
  • K212807 — Surgical Masks (December 3, 2021)
  • K120192 — DISPOSABLE SURGICAL GOWNS (October 16, 2012)

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)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)
  • K140250 — 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (July 25, 2014)