510(k) K840957

ANTIMICROBIAL INCISE DRAPE by American Convertors Div., American Pharmaseal — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 7, 1984
Date Received: March 6, 1984
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 Convertors Div., American Pharmaseal

K832137 — CONVERTORS FLASH STERILIZING TRAY (August 12, 1983)
K830786 — DISIMETRIC RELEASE OF INSTRANETICS RAD (May 18, 1983)
K820994 — ABSORB FURN SHEET (May 13, 1982)
K813419 — COMFORT CUSHION DRY BURN PAD III (January 22, 1982)
K813296 — CONVERTORS STERILE DISP. LAP SPONGE II (December 29, 1981)
K813078 — CONTURA DISPOS. SURG. FACE MASK (December 18, 1981)
K812554 — TOMAC STERILE DISP. LAP SPONGE (September 24, 1981)
K802919 — ISO-BAC INSTRUMENT WRAP (February 2, 1981)
K802998 — PATIENT CARE DISPOSABLE INFANT SHIRTS (December 22, 1980)
K802359 — DISP. FENESTRATED SURG. DRAPE SHEETS (October 31, 1980)

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)