# K213907: CareGUARD Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Care Essentials Pty, Ltd.
- Decided: Mar 14, 2022 after 90 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 K881471 (1988). 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)
- K082554: Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600, Kimberly-Clark Corp. (2009) Summary page 4.

## Indications for use
CareGUARD* Sterilization Wrap is a single-use, non-woven sterilization wrap intended to be sterilized by a health care provider using pre-vacuum steam at 273°F / 134°C for 4 minutes. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. The CareGUARD* Sterilization wrap is recommended to be used with trays weighing up to 13.7 lbs. The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used. Test results validated that CareGUARD™* Sterilization wraps allowed sterilization of the enclosed devices by pre-vacuum cycles. Refer to Table 1 for recommendations for use per Pre-vacuum steam Sterility Maintenance Study. Table 1: Basis weight recommendations for pre-vacuum steam Basis Weight Maximum Wrapped Package Content Weight 50 GSM 60 GSM 6.2 kg/ 13.7 lbs 75 GSM The following load was used in the Pre-vacuum steam Sterility Maintenance Study: * 50GSM: 21 in. x 10 in. x 4 % in. (54 cm x 25 cm x 12 cm) tray containing 13.7 lbs (6.2 kg) of metal mass The metal mass included surgical instruments used for orthopedic joint replacement

Source page: https://510kreport.com/device/K213907
Methodology: https://510kreport.com/methodology