# K220133: Sterilization Wraps

- Pathway: 510(k) (Traditional)
- Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
- Decided: Mar 10, 2022 after 51 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: 7 generations back to K881471 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182656: JAMBRO Single Core A Sterilization wrap, Jiangsu Zhande Medical Supplies Co., Ltd. (2019) Summary page 5.

## Indications for use
Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: * Pre-vacuum steam at 270°F/132°C for 4 minutes Types of medical devices to be sterilized in the pre-vacuum cycle: General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusion-restricted spaces such as forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc. The size of the Devices to be sterilized shall allow Sterilization Wraps pack and form a closed space. Validated for dry time is 30 minutes for Sterilization Wraps. Color of wrap: Blue Size of wrap: 48 in x 48 in The maximum validated weight of load for Sterilization Wraps is 12kg. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.

Source page: https://510kreport.com/device/K220133
Methodology: https://510kreport.com/methodology