510(k) Report

Devices descending from K210030

4 later devices reach Medical Surgical Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231719Medical Surgical MaskAzur Medical Company, Inc.20240—
+1K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd.20221—
+1K212299Medical Surgical MaskWepon Medical Technology Co., Ltd.20220—
+2K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.20260—