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510(k) K994199

VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR by Custom Medical Products, Inc. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 9, 2000
Date Received: December 13, 1999
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 Custom Medical Products, Inc.

K931417 — STERILE EQUIPMENT COVERS (July 6, 1995)
K931456 — SURGICAL DRAPE AND GOWN TRAY (July 8, 1994)
K930815 — ABDOMINAL / THORACIC PATIENT DRAPE (May 5, 1994)
K931418 — SURGICAL DRAPE (May 5, 1994)
K931455 — HEAD SHEET (May 5, 1994)
K931844 — CUSTOM PROCEDURE MEDICAL TRAY OR KIT (January 25, 1994)
K926519 — SURGICAL GOWN (August 12, 1993)
K900847 — ENEMA KIT 'Y' DESIGN (April 13, 1990)
K900848 — ENEMA KIT 'STRAIGHT' DESIGN (April 13, 1990)
K895084 — APERTURE (October 27, 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)