FDA 510(k)

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)

Número K: K231510 · 2023-08-22

RequerenteXiantao Zhibo Non-Woven Products Co., Ltd.

Data da decisão2023-08-22

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Zhibo Non-Woven Products Co., Ltd.. It received FDA 510(k) clearance on 2023-08-22 under 510(k) number K231510. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)?

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) is a medical device that received FDA 510(k) clearance on 2023-08-22. The listed applicant is Xiantao Zhibo Non-Woven Products Co., Ltd.. The 510(k) number is K231510.

When did Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) receive FDA 510(k) clearance?

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-08-22, under 510(k) number K231510.

Who is the listed applicant for Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)?

The FDA 510(k) record lists Xiantao Zhibo Non-Woven Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)?

The FDA product code for Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) is FYA.

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Fonte oficial

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