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FDA 510(k)

PHMB Wound Dressing

K-Number: K221532 · 2023-01-30

ApplicantWinner Medical Co., Ltd.
Decision Date2023-01-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PHMB Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-01-30 under 510(k) number K221532. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHMB Wound Dressing?

PHMB Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-01-30. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K221532.

When did PHMB Wound Dressing receive FDA 510(k) clearance?

PHMB Wound Dressing received FDA 510(k) clearance on 2023-01-30, under 510(k) number K221532.

Who is the listed applicant for PHMB Wound Dressing?

The FDA 510(k) record lists Winner Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHMB Wound Dressing?

The FDA product code for PHMB Wound Dressing is FRO. This falls under the Anesthesiology category.

Other records listing Winner Medical 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.

K252001Collagen Wound DressingK250082Procedure mask/Surgical mask/Face maskK231057Antibacterial Gel Wound DressingK231564Skin and Wound CleanserK231152Collagen Wound DressingK221311Antibacterial Bandage

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Related Devices (Code: FRO)

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, 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.

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