510(k) · Cleared
ClearedSterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Zonsen Medical Products Co., Ltd. · FRG Wrap, Sterilization
Cleared on Aug 25, 2023 as substantially equivalent to K160755 (Ahlstrom Nonwovens, LLC, 2016) after a 266-day review. Its family tree reaches back 6 generations to 1988.
- Decided
- Aug 25, 2023
- Review
- 266 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K881471 (1988). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 5 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 4 generations backK092167 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 3 generations backK113806 Kimguard One Step Sterilization WrapKimberly-Clark Health Care · 2013
- 2 generations backK141612 Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014
- 1 generation backK160755 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016
- This deviceK223600 Sterilization WrapWuhan Zonsen Medical Products Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −5 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −4 | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400… | Kimberly-Clark Corp. | 2009 | — |
| −3 | K113806 | Kimguard One Step Sterilization Wrap | Kimberly-Clark Health Care | 2013 | — |
| −2 | K141612 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Health Care | 2014 | — |
| −1 | K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens, LLC | 2016 | — |
| 0 (this device) | K223600 | Sterilization Wrap | Wuhan Zonsen Medical Products Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
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 FRG? 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 FRG device
- #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapSummary page 4…cess Device Class: Class II Classification Panel: General Hospital Product Code: FRG Regulation Number: 21 CFR 880.6850 4. Pr edicate Devices Primary Predicate Device: K160755 Product Name: Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap Submitter: Ahlstrom Nonwovens LLC… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K160755.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 0 | — |
What is it indicated for?
Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: A) Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes dry time. B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 ºC Model: ZSW1610, ZSW 1611. Material: 45gms SMS, 54gms SMS. Color of wrap…
Read the full statement (228 words)
Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider
via the following:
A) Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes dry time.
B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40%
relative humidity for 480 minutes, 24 hours aeration time at 42 ºC
Model: ZSW1610, ZSW 1611.
Material: 45gms SMS, 54gms SMS.
Color of wrap: Pink/Blue (double layers).
Size (inches): 12*12, 15*15, 18*18, 20*20, 24*24, 30*30, 36*36, 40*40, 45*45, 48*48, 54*54, 72*54.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain
sterility of the enclosed device(s) up to 90 days post sterilization.
Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization:
General purpose non-lumened reusable metal and nonmetal devices including devices with stainless steel diffusionrestricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc.
Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of
each types, range from 2lbs to 9lbs, which dependent on each model's size.
For size2*12, 15*15, 18*18, maximum weight is 2lb, for 20*20, 24*24, 30*30, 36*36, 40*40, 45*45, 48*48, maximum
weight is 6lb, and for 54*54, 72*54, maximum weight is 9lb.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223600 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223600: Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223600
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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