# K983719: Bioshield Express Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Aug 25, 1999 after 308 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 K770933 (1977). 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)
- K770933: Bio-Shield CSR Wrap, Convertors (1977) Summary page 1.
- (no number) Dextex II Sterilization Wrap: named in the summary without a submission number
- (no number) Kimguard™ Sterilization: named in the summary without a submission number
- (no number) Allegiance BioShield® Sterilization Wrap: named in the summary without a submission number

## Most influential descendants
- K993871: Bioshield Heavy Duty and Super Duty Express Sterilization Wrap (2000), 0 descendants of its own

## Indications for use
The Bioshield® 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 prevacuum steam sterilization processes.

Source page: https://510kreport.com/device/K983719
Methodology: https://510kreport.com/methodology