# K990300: Suprashield Express Sterilization Wrap

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: Feb 10, 1999 after 9 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 K921243 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921243: Convertors Sterilization Wrap, Baxter Healthcare Corp (1992) Summary page 1.

## Most influential descendants
- K080198: TSO3 Ozone Sterilization Wrap (2008), 0 descendants of its own

## Indications for use
The SupraShield® Express™ Sterilization Wrap is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This wrap is intended for use in steam or ethylene oxide (EO) sterilization processes.

Source page: https://510kreport.com/device/K990300
Methodology: https://510kreport.com/methodology