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FDA 510(k)

Vinyl/Nitrile Blend Exam Glove

K-Number: K213634 · 2022-02-18

ApplicantDezhou Hengchang Medical Technology Co., Ltd.
Decision Date2022-02-18
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vinyl/Nitrile Blend Exam Glove is the device name listed in this FDA 510(k) record. The listed applicant is Dezhou Hengchang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K213634. 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 Vinyl/Nitrile Blend Exam Glove?

Vinyl/Nitrile Blend Exam Glove is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Dezhou Hengchang Medical Technology Co., Ltd.. The 510(k) number is K213634.

When did Vinyl/Nitrile Blend Exam Glove receive FDA 510(k) clearance?

Vinyl/Nitrile Blend Exam Glove received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213634.

Who is the listed applicant for Vinyl/Nitrile Blend Exam Glove?

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

What is the FDA product code for Vinyl/Nitrile Blend Exam Glove?

The FDA product code for Vinyl/Nitrile Blend Exam Glove is LYZ.

Other records listing Dezhou Hengchang Medical 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.

K220055Disposable, vinyl examination gloves, YellowK213625Vinyl Examination Gloves

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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