# K162162: Barrier Supreme Sterilization Wrapper

- Pathway: 510(k) (Traditional)
- Applicant: Standard Textile Co., Inc.
- Decided: Nov 4, 2016 after 94 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 K923408 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923408: Wrappel T, Standard Textile Co., Inc. (1993) Summary page 5.

## Indications for use
Barrier Supreme Sterilization Wrappers are intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. Barrier Supreme Sterilization Wrappers will function as a sterilization wrap when processed according to instructions. Barrier Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile sterilization wraps that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies. Pack Assembly: Pack assembly should follow established folding, assembly and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. The oblong and envelope folds have been validated for use on textile packs. Closure can include autoclave tape and elastomer closures. Sterilization: A prevacuum steam sterilization cycle (4 minute exposure at 270oF) has been validated for use on textile packs. The maximum pack size validated for use was 0.58 cubic feet with a pack weight of 23.2 pounds – pack density of 40.0 lbs./cu.ft. The maximum chamber loading configuration included 96 pounds of packs in a 9.1 cubic foot chamber – load density of 10.6 lbs./cu.ft.

Source page: https://510kreport.com/device/K162162
Methodology: https://510kreport.com/methodology