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FDA 510(k)

RoyalGuard Surgical Gown, i600, Breathable

K-Number: K172445 · 2017-12-08

ApplicantGri Medical & Electrical Technology Co., Ltd.
Decision Date2017-12-08
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RoyalGuard Surgical Gown, i600, Breathable is the device name listed in this FDA 510(k) record. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K172445. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RoyalGuard Surgical Gown, i600, Breathable?

RoyalGuard Surgical Gown, i600, Breathable is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K172445.

When did RoyalGuard Surgical Gown, i600, Breathable receive FDA 510(k) clearance?

RoyalGuard Surgical Gown, i600, Breathable received FDA 510(k) clearance on 2017-12-08, under 510(k) number K172445.

Who is the listed applicant for RoyalGuard Surgical Gown, i600, Breathable?

The FDA 510(k) record lists Gri Medical & Electrical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RoyalGuard Surgical Gown, i600, Breathable?

The FDA product code for RoyalGuard Surgical Gown, i600, Breathable is FYA.

Other records listing Gri Medical & Electrical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163191ComfortGuard Surgical Gown, i600, Film ReinforcedK162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

Related Devices (Code: FYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLCK253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)Hubei Xinxin Non-Woven Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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