# K993871: Bioshield Heavy Duty and Super Duty Express Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Apr 21, 2000 after 158 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: 2 generations back to K770933 (1977). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983719: Bioshield Express Sterilization Wrap, Allegiance Healthcare Corp. (1999) Summary page 2.

## Indications for use
The Bioshield® Express™ Heavy Duty & Super Duty 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 Ethylene Oxide and Gravity Steam sterilization processes.

Source page: https://510kreport.com/device/K993871
Methodology: https://510kreport.com/methodology