Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sterilization Wraps

K-Number: K220133 · 2022-03-10

ApplicantWeihai Hongyu Nonwoven Fabric Products Co., Ltd.
Decision Date2022-03-10
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilization Wraps is the device name listed in this FDA 510(k) record. The listed applicant is Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K220133. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterilization Wraps?

Sterilization Wraps is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. The 510(k) number is K220133.

When did Sterilization Wraps receive FDA 510(k) clearance?

Sterilization Wraps received FDA 510(k) clearance on 2022-03-10, under 510(k) number K220133.

Who is the listed applicant for Sterilization Wraps?

The FDA 510(k) record lists Weihai Hongyu Nonwoven Fabric Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Wraps?

The FDA product code for Sterilization Wraps is FRG.

Other records listing Weihai Hongyu Nonwoven Fabric Products Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K214088Disposable Surgical GownK213029Nitrile Examination Gloves (Powder free, Blue)K212807Surgical Masks

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑