Home / 510(k) Clearances / K252167

510(k) K252167

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) by Qingdao Bright Moon Biomedical Materials Co., Ltd. — Product Code FRO

K252167 is an FDA 510(k) premarket notification submitted by Qingdao Bright Moon Biomedical Materials Co., Ltd. for the device "Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)". The FDA issued a decision of Substantially Equivalent on December 19, 2025. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Qingdao Bright Moon Biomedical Materials Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
July 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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

  • K220673 — Sterile Silver Alginate Wound Dressing (March 16, 2023)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources