Cleared Traditional

Sterilization Wraps

K220133 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
Mar 2022
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K220133 is an FDA 510(k) clearance for the Sterilization Wraps, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on March 10, 2022, 51 days after receiving the submission on January 18, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K220133 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2022
Decision Date March 10, 2022
Days to Decision 51 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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