# K962605: Pro-Guard Double-Duty Sterilization Wrap (Single Use)

- Pathway: 510(k) (Traditional)
- Applicant: Surgicot, Inc.
- Decided: Mar 11, 1997 after 252 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dexter: named in the summary without a submission number
- (no number) Surgicot Surgiwrap: named in the summary without a submission number
- (no number) Surgicot Pro-Guard Regular: named in the summary without a submission number
- (no number) Surgicot Pro-Guard Heavy Duty: named in the summary without a submission number
- (no number) Kimberly-Clark Kimguard Regular: named in the summary without a submission number
- (no number) Kimberly-Clark Kimguard Heavy Duty: named in the summary without a submission number
- (no number) Kimberly-Clark Kimguard Ultra: named in the summary without a submission number
- (no number) Kimberly-Clark Kimguard One Step: named in the summary without a submission number
- (no number) American Threshold Secure-Wrap: named in the summary without a submission number

## Indications for use
Pro-Guard Double Duty, like the other wrap products available, is intended to wrap other medical devices for exposure to saturated steam or ethylene oxide sterilization processes and to maintain sterilization for a reasonable time under reasonable conditions.

Source page: https://510kreport.com/device/K962605
Methodology: https://510kreport.com/methodology