510(k) K980183

PROMAX SURGICAL DRAPES AND COVERS by Standard Textile Co., Inc. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 26, 1998
Date Received: January 20, 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 Standard Textile Co., Inc.

K241214 — ProPel SG3 Surgical Gown (September 10, 2024)
K172207 — Standard Supreme Sterilization Wrapper (August 25, 2017)
K162162 — Barrier Supreme Sterilization Wrapper (November 4, 2016)
K060181 — COMPE1 1 -PLY SURGICAL GOWNS (March 7, 2006)
K041653 — COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS (July 1, 2005)
K041540 — COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS (May 5, 2005)
K041539 — COMPEL SURGICAL GOWNS (April 28, 2005)
K041541 — COMPEL MLR SURGICAL GOWNS (March 16, 2005)
K012268 — TRIMAX (December 3, 2001)
K012807 — MODIFICATION TO: COMPEL SURGICAL DRAPES (October 11, 2001)

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)