Home / 510(k) Clearances / K202577

510(k) K202577

Medical Surgical Mask-Model MP002-5, MP002-6 by Jiangmen Sure&Me Medical Product Co., Ltd. — Product Code FXX

K202577 is an FDA 510(k) premarket notification submitted by Jiangmen Sure&Me Medical Product Co., Ltd. for the device "Medical Surgical Mask-Model MP002-5, MP002-6". The FDA issued a decision of Substantially Equivalent on Jan 11, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 11, 2021
Date Received
Sep 8, 2020
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
510(k)

Other clearances for product code FXX

  • K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO… (Mar 18, 2026)
  • K252534 — Surgical Face Mask (Ear mount) (Mar 3, 2026)
  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (Feb 19, 2026)
  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (Jan 12, 2026)
  • K252650 — Disposable Medical Face Mask (Jan 5, 2026)
  • K243342 — KP Protective Face Mask (Dec 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (Dec 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (Nov 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with… (Sep 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (Jun 18, 2025)

FDA data resources