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FDA 510(k)

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing

K-Number: K221755 · 2023-01-13

ApplicantWinner Medical Co., Ltd.
Decision Date2023-01-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing is a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under approval number K221755. 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 Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing?

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K221755.

When was Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing approved by the FDA?

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing received FDA 510(k) clearance on 2023-01-13, under approval number K221755.

What company makes Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing?

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing is manufactured by Winner Medical Co., Ltd..

What is the FDA product code for Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing?

The FDA product code for Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT05741866 Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) COMPLETED NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT07066254 The Mepilex Cesarean Delivery Trial NOT_YET_RECRUITING

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)

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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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