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 Wrap

K-Number: K222151 · 2023-03-23

ApplicantKenpax International Limited
Decision Date2023-03-23
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Kenpax International Limited. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K222151. 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 Wrap?

Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Kenpax International Limited. The 510(k) number is K222151.

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

Sterilization Wrap received FDA 510(k) clearance on 2023-03-23, under 510(k) number K222151.

Who is the listed applicant for Sterilization Wrap?

The FDA 510(k) record lists Kenpax International Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Wrap?

The FDA product code for Sterilization Wrap is FRG.

Other records listing Kenpax International Limited 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.

K222128Protective Gown AAMI Level 4K212504Isolation Gown AAMI Level 3K202899Procedure Mask, Surgical Mask

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.

↑