FDA 510(k)

SURGICAL ISOLATION GOWN

K-Number: K171535 · 2018-02-15

ApplicantJingzhou Haixin Green Cross Medical Products Co., Ltd.

Decision Date2018-02-15

Product CodeFYC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGICAL ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Jingzhou Haixin Green Cross Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-02-15 under 510(k) number K171535. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL ISOLATION GOWN?

SURGICAL ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 2018-02-15. The listed applicant is Jingzhou Haixin Green Cross Medical Products Co., Ltd.. The 510(k) number is K171535.

When did SURGICAL ISOLATION GOWN receive FDA 510(k) clearance?

SURGICAL ISOLATION GOWN received FDA 510(k) clearance on 2018-02-15, under 510(k) number K171535.

Who is the listed applicant for SURGICAL ISOLATION GOWN?

The FDA 510(k) record lists Jingzhou Haixin Green Cross Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL ISOLATION GOWN?

The FDA product code for SURGICAL ISOLATION GOWN is FYC.

Other records listing Jingzhou Haixin Green Cross Medical Products Co., Ltd. as applicant

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K222266Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

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Official Source

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