Cleared Traditional

CareGUARD Sterilization Wrap

K213907 · Care Essentials Pty, Ltd. · General Hospital
Mar 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K213907 is an FDA 510(k) clearance for the CareGUARD Sterilization Wrap, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Care Essentials Pty, Ltd. (North Geelong, AU). The FDA issued a Cleared decision on March 14, 2022, 90 days after receiving the submission on December 14, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K213907 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2021
Decision Date March 14, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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