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510(k) K210908

Surgical Mask by Sichuan Prius Biotechnology Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2021
Date Received
March 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Sichuan Prius Biotechnology Co., Ltd.

  • K221075 — Infusion Sets for Single Use (November 21, 2022)
  • K221069 — Infusion Sets for Single Use with Needles (November 21, 2022)
  • K221078 — Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use (November 21, 2022)
  • K221068 — Sterile Hypodermic Syringes for Single Use with Needles (October 4, 2022)
  • K221066 — Sterile Hypodermic Needles for Single Use (October 4, 2022)
  • K221080 — Sterile Safety Hypodermic Needles for Single Use (October 4, 2022)
  • K221073 — Sterile Hypodermic Syringes for Single Use with Safety Needles (October 4, 2022)
  • K221079 — Sterile Hypodermic Syringes for Single Use (October 4, 2022)

Other clearances for product code FXX

  • K252534 — Surgical Face Mask (Ear mount) (March 3, 2026)
  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (February 19, 2026)
  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (January 12, 2026)
  • K252650 — Disposable Medical Face Mask (January 5, 2026)
  • K243342 — KP Protective Face Mask (December 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (December 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S (September 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
  • K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); (May 30, 2025)