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510(k) K213450

Medical surgical mask (Black mask, Level 1 and Level 3) by Guangdong Kingfa Sci. & Tech.Co., Ltd. — Product Code FXX

K213450 is an FDA 510(k) premarket notification submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. for the device "Medical surgical mask (Black mask, Level 1 and Level 3)". The FDA issued a decision of Substantially Equivalent on April 5, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Guangdong Kingfa Sci. & Tech.Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2022
Date Received
October 26, 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 Guangdong Kingfa Sci. & Tech.Co., Ltd.

  • K233723 — Medical surgical mask (July 29, 2024)
  • K231155 — Biodegradable Medical surgical mask (November 7, 2023)
  • K221983 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable P (April 27, 2023)
  • K230046 — Vinyl examination gloves (March 25, 2023)
  • K222612 — Powder-Free Latex examination gloves (November 25, 2022)
  • K222714 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, (October 7, 2022)
  • K221887 — Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, N (September 24, 2022)
  • K213040 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, (April 27, 2022)
  • K211220 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, (July 22, 2021)
  • K203593 — Patient Examination Gloves (March 19, 2021)

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