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510(k) K210908

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

K210908 is an FDA 510(k) premarket notification submitted by Sichuan Prius Biotechnology Co., Ltd. for the device "Surgical Mask". The FDA issued a decision of Substantially Equivalent on September 26, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Sichuan Prius Biotechnology Co., Ltd. has at least 8 other 510(k) clearances on record.

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.

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

Other clearances for product code FXX

  • K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT (March 18, 2026)
  • 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)

FDA data resources