Disposable Surgical Face Mask (3P00B, C2900)— 510(k) K252830

Name: FDA 510(k) clearance K252830
Creator: U.S. Food and Drug Administration
Published: 2026-01-12

Substantially Equivalent

Beatles Medical Supplies (Xiantao) Co., Ltd.

FDA 510(k) clearance K252830 for Disposable Surgical Face Mask (3P00B, C2900), Substantially Equivalent on 2026-01-12. Applicant: Beatles Medical Supplies (Xiantao) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beatles Medical Supplies (Xiantao) Co., Ltd.
Product code: Code FXX
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2025-09-05
Decision date: 2026-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiantao, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FXX

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K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more2026-03-18
K252534 — Surgical Face Mask (Ear mount)2026-03-03
K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)2026-02-19
K252650 — Disposable Medical Face Mask2026-01-05
K243342 — KP Protective Face Mask2025-12-22

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.