510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Medline Disposable Surgical Drapes and Gowns

K964142510(k) TraditionalCleared Feb 25, 1997132-day reviewClass II21 CFR 878.4370Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medline Industries, Inc. · KKX Drape, Surgical, Antimicrobial

Cleared on Feb 25, 1997 after a 132-day review. The FDA summary names no predicate by number. 29 later devices descend from it. It has been recalled 3 times.

Decided
Feb 25, 1997
Review
132 days
Class
Class II
Product code
KKX
Recalls
3
Predicates
0

29 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2010: 2 descendants cleared2004: 1 descendant cleared2011: 1 descendant cleared2001: 1 descendant cleared2007: 2 descendants cleared2012: 1 descendant cleared2018: 1 descendant cleared2022: 7 descendants cleared2021: 7 descendants cleared2024: 2 descendants cleared2023: 2 descendants cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997
  2. Descendant · cites it directly · 23 of its ownK012186 Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd. · 2001
  3. Descendant · 2 generations on · 21 of its ownK100971 Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010
  4. Descendant · 3 generations on · 20 of its ownK120192 Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · Recalled
  5. Descendant · 4 generations on · 19 of its ownK172987 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001…Gmax Industries, Inc. · 2018
  6. Descendant · 5 generations on · 11 of its ownK211422 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12004: 12007: 22010: 22011: 12012: 12018: 12021: 72022: 72023: 22024: 22026: 1
2001high 7 (2021) · low 0 (2003)2026

Most influential descendants

Showing 5 of 29 · See all
  • K012186Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd. · 2001 · cites it directly23descendants
  • K100971Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010 · 2 generations on21descendants
  • K120192Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · 3 generations on20descendants
  • K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc. · 2018 · 4 generations on19descendants
  • K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021 · 5 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964142Medline Disposable Surgical Drapes and GownsMedline Industries, Inc.1997—
+1K012186Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd.2001—
+2K100971Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd.2010—
+3K120192Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20121
+4K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc.2018—
+5K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200410
200720
201020
201110
201210
201810
202170
202270
202320
202420
202610
FIG. 1 — Lineage of K964142, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KKX device

  1. #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (29)

See all 29

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012186Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd.200123
K020393Master & Frank Surgical Drapes (Sterile)Master & Frank Enterprses Co., Ltd.20021
K111535Emm Surgical Gown - Spunlace with PE LayerExact Medical Manufacturing, Inc.20110
K101688Emm Surgical Drape-Spunlace W/PE Sides, Model 13-004Exact Medical Manufacturing, Inc.20100
K042131Promedical Surgical DrapesPromedical Products Co., Ltd.20040

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 11, 2018Class IIZ-2010-2018Under Investigation by firmProduct sterility may be compromised due to unsealed packaging.
Apr 11, 2018Class IIZ-1963-2018Under Investigation by firmProduct sterility may be compromised due to unsealed packaging.
Jun 1, 2017Class IIZ-3079-2017OtherThe sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K012186 (Master & Frank Ent. Co., Ltd., 2001) has gone furthest, with 23 descendants of its own.

How does its category compare?

All KKX devices

KKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KKX

2in 2023

2007: 42008: 52009: 52010: 82011: 42012: 22013: 32014: 62015: 22017: 12020: 12021: 12023: 2
2007high 8 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KKX

182in 2014

2007: 181 days median2008: 164 days median2009: 114 days median2010: 107 days median2011: 147 days median2013: 227 days median2014: 182 days median
2007high 227 (2013) · low 107 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KKX

2in 2024

2007: 12010: 12011: 12012: 12013: 72014: 7, 7 Class I2016: 42024: 22026 (partial year): 2
2007high 7 (2013) · low 0 (2008)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KKX

24in 2025

2007: 242008: 242009: 272010: 252011: 572012: 402013: 632014: 282015: 332016: 562017: 302018: 322019: 412020: 162021: 412022: 192023: 322024: 192025: 24
2007high 63 (2013) · low 16 (2020)2025

MAUDE reports naming product code KKX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074181124
20085164024
20095114027
20108107125
20114147157
20122—140
20133227763
201461827 (7)28
20152—033
20160—456
20171—030
20180—032
20190—041
20201—016
20211—041
20220—019
20232—032
20240—219
20250—024
20260—2—

More from Medline Industries, Inc.

238 FDA decisions under this applicant name. See the company

  • DEN210049Medline ART Skin Harvesting SystemMedline Industries, Inc. · 2024
  • K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier…Medline Industries, Inc. · 2023
  • K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)Medline Industries, Inc. · 2023
  • K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc. · 2023
  • K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc. · 2022

Recent decisions in KKX

The KKX category page

  • K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical, Ltd. · 2023
  • K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company · 2023
  • K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba · 2021
  • K200238ControlRad Sterile CoverControlrad, Inc. · 2020
  • K163556MediClear PreOpCovalontechnologies, Inc. · 2017

https://510kreport.com/device/K964142 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964142: Medline Disposable Surgical Drapes and Gowns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964142

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026