510(k) Report

Devices descending from K212861

2 later devices reach Surgical Gown, Reinforced Surgical Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231510Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)Xiantao Zhibo Non-Woven Products Co., Ltd.20231—
+2K233183Surgical Gown (40083)Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.20240—