# K223600: Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Zonsen Medical Products Co., Ltd.
- Decided: Aug 25, 2023 after 266 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K881471 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160755: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap, Ahlstrom Nonwovens, LLC (2016) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K223600
Methodology: https://510kreport.com/methodology