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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 the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Bright Moon Biomedical Materials Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) 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. The listed applicant is Qingdao Bright Moon Biomedical Materials Co., Ltd.. The 510(k) number is K252167.

When did Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) receive FDA 510(k) clearance?

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

Who is the listed applicant for Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)?

The FDA 510(k) record lists Qingdao Bright Moon Biomedical Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Qingdao Bright Moon Biomedical Materials 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.

K220673Sterile Silver Alginate Wound Dressing

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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