510(k) K912110

DISPOSABLE O.R. TOWEL by American Threshold Industries, Inc. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 25, 1991
Date Received: May 13, 1991
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 American Threshold Industries, Inc.

K971483 — SECURE-WRAP (TM) STERILIZATION WRAP (June 24, 1997)
K953879 — SURGEON'S CAP (January 5, 1996)
K953878 — BOUFFANT CAP (January 5, 1996)
K952114 — KOOL GARD SINGLES GOWN (September 25, 1995)
K952115 — BARRIER GOWN, KOOL-GARD BACKLESS GOWN (September 25, 1995)
K952116 — COVER GOWN (September 5, 1995)
K934085 — MODIFICATION OF SURGICAL EYESHIELD MASK (November 12, 1993)
K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)
K915740 — DISPOSABLE O.R. TOWEL, STERILE (June 22, 1992)
K894383 — DISPOSABLE SHOE COVER (September 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)