# K162993: Gemini Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jun 23, 2017 after 239 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: 5 generations back to K881471 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150698: Gemini Sterilization Wrap, Medline Industries, Inc. (2015) Summary page 4.

## Indications for use
Gemini Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of such content until used. Gemini Sterilization Wrap is validated for use in the following sterilization processes modes and cycles:

Source page: https://510kreport.com/device/K162993
Methodology: https://510kreport.com/methodology