510(k) Report

Devices descending from K202594

2 later devices reach Medical Surgical Masks-Non Sterile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221409Paneffort 3-ply Surgical and Procedural MasksPaneffort, LLC20220—
+1K212807Surgical MasksWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20210—