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FDA 510(k)

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

K-Number: K252167 · 2025-12-19

ApplicantQingdao Bright Moon Biomedical Materials Co., Ltd.
Decision Date2025-12-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is a medical device manufactured by Qingdao Bright Moon Biomedical Materials Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under approval number K252167. 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 Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)?

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Qingdao Bright Moon Biomedical Materials Co., Ltd.. The 510(k) number is K252167.

When was Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) approved by the FDA?

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) received FDA 510(k) clearance on 2025-12-19, under approval number K252167.

What company makes Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)?

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is manufactured by Qingdao Bright Moon Biomedical Materials Co., Ltd..

What is the FDA product code for Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)?

The FDA product code for Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is FRO. This falls under the Anesthesiology category.

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Related PubMed Literature

PMID: 41966058 Artificial intelligence in personalized prescription: A narrative review of promise, peril, and practicality. Therapie (2026)

Other Devices by Qingdao Bright Moon Biomedical Materials Co., Ltd.

K220673Sterile Silver Alginate Wound Dressing

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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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