# K143147: Gemini Bonded Sterilization Wrap

- Pathway: 510(k) (Special)
- Applicant: Medline Industries, Inc.
- Decided: May 7, 2015 after 185 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: 1 generation back to K113353 (2013). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113353: Gemini Sterilzation Wrap, Medline Industries, Inc. (2013) Summary page 9.

## Most influential descendants
- K152458: Gemini Bonded Sterilization Wrap (2016), 1 descendant of its own
- K192641: Gemini Titan Sterilization Wrap (2020), 0 descendants of its own

## Indications for use
Gemini Bonded Sterilization Wrap is 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 for 180 days following sterilization. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles. • Pre-vacuum steam cycles * Minimum 4 Minutes Exposure at 270ºF/132ºC with minimum 20 minutes dry time • Gravity steam cycles * Maximum 30 Minutes Exposure at 250ºF/121ºC with minimum 20 minutes dry time • STERRAD® Sterilization * STERRAD® 100NX, Flex cycle * STERRAD® 100NX, Standard cycle * STERRAD® 100NX, Express cycle * STERRAD® 100S, Standard cycle * STERRAD® NX, Advanced cycle * STERRAD® NX, Standard cycle The Gemini Bonded Sterilization Wrap intended loads with pre-vacuum steam sterilization, gravity steam sterilization, and the Advanced Sterilization Products (ASP) STERRAD® 100NX, STERRAD® 100S, and STERRAD® NX cycles are provided in Table 1. The Gemini Bonded Sterilization Wrap Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems are provide in Table 2.

Source page: https://510kreport.com/device/K143147
Methodology: https://510kreport.com/methodology