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FDA 510(k)

Sterile Silver Alginate Wound Dressing

K-Number: K220673 · 2023-03-16

ApplicantQingdao Bright Moon Biomedical Materials Co., Ltd.
Decision Date2023-03-16
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Sterile Silver Alginate Wound Dressing is a medical device manufactured by Qingdao Bright Moon Biomedical Materials Co., Ltd.. It received FDA 510(k) clearance on 2023-03-16 under approval number K220673. 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 Sterile Silver Alginate Wound Dressing?

Sterile Silver Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-03-16. It is manufactured by Qingdao Bright Moon Biomedical Materials Co., Ltd.. The 510(k) number is K220673.

When was Sterile Silver Alginate Wound Dressing approved by the FDA?

Sterile Silver Alginate Wound Dressing received FDA 510(k) clearance on 2023-03-16, under approval number K220673.

What company makes Sterile Silver Alginate Wound Dressing?

Sterile Silver Alginate Wound Dressing is manufactured by Qingdao Bright Moon Biomedical Materials Co., Ltd..

What is the FDA product code for Sterile Silver Alginate Wound Dressing?

The FDA product code for Sterile Silver Alginate 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: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) 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 Qingdao Bright Moon Biomedical Materials Co., Ltd.

K252167Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)

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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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