Cleared Traditional

Surgical Face Mask (Ear mount)

K252534 · Zhejiang Hangkang Medical Equipment Co., Ltd. · General Hospital

Mar 2026

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K252534 is an FDA 510(k) clearance for the Surgical Face Mask (Ear mount), a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Zhejiang Hangkang Medical Equipment Co., Ltd. (Yiwu, CN). The FDA issued a Cleared decision on March 3, 2026, 203 days after receiving the submission on August 12, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K252534 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2025
Decision Date	March 03, 2026
Days to Decision	203 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement