510(k) K812962

BOUNDARY SURGICAL DRAPE by The Buckeye Cellulose Corp. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 20, 1981
Date Received: October 22, 1981
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 The Buckeye Cellulose Corp.

K822925 — BOUNDARY SINGLE-USE GOWNS (January 12, 1983)
K823173 — ARRIRM SCRUB BRUSH/SPONGE (November 22, 1982)
K821564 — BOUNDARY PROCESS CHANGE (July 2, 1982)
K820758 — BOUNDARY SINGLE-USE CRANIOTOMY SHEET (April 29, 1982)
K820116 — BOUNDARY (February 23, 1982)
K813450 — BOUNDARY SINGLE-USE DRAPES (January 22, 1982)
K813390 — BONDARY SINGLE-USE OR GOWN (January 5, 1982)
K813277 — BOUNDARY DRAPE TAPE (December 18, 1981)
K813263 — PATIENT UNDERPAD (November 27, 1981)
K812738 — BOUNDARY PROCESS CHANGE (November 16, 1981)

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)