Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) (K231510) — FDA 510(k) Clearance | Predicase

K-number	K231510
Device name	Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
Applicant	Xiantao Zhibo Non-Woven Products Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Aug 22, 2023
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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