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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 a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-01-30 under approval 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. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K221532.

When was PHMB Wound Dressing approved by the FDA?

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

What company makes PHMB Wound Dressing?

PHMB Wound Dressing is manufactured by Winner Medical Co., Ltd..

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.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Winner Medical Co., Ltd.

K181315Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border K192463PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) K221720Extra Silver Gelling Fiber Dressing K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown

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Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

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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