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FDA 510(k)

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue

K-Number: K153028 · 2016-02-05

ApplicantZibo Huiying Medical Products, Co. , Ltd.
Decision Date2016-02-05
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Huiying Medical Products, Co. , Ltd.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K153028. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue?

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Zibo Huiying Medical Products, Co. , Ltd.. The 510(k) number is K153028.

When did Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue receive FDA 510(k) clearance?

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue received FDA 510(k) clearance on 2016-02-05, under 510(k) number K153028.

Who is the listed applicant for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue?

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

What is the FDA product code for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue?

The FDA product code for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue is LYZ.

Related Devices (Code: LYZ)

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.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Official Source

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

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