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510(k) K212610

Surgical Face Mask by Foshan Nanhai Plus Medical Co, Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2022
Date Received
August 17, 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 Foshan Nanhai Plus Medical Co, Ltd.

  • K222480 — Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) (November 14, 2022)
  • K213177 — Plus Medical Cover Gown (May 11, 2022)
  • K211036 — Plus Medical Chemotherapy Gown (May 4, 2022)
  • K212698 — Plus Medical Isolation Gown Level 3 (March 2, 2022)
  • K210143 — Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) (July 22, 2021)
  • K133075 — Plus Surgical Gowns (EO Sterilized), PMGB-XXX (June 24, 2015)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)

Other clearances for product code FXX

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  • 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)