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FDA 510(k)

Powder-Free Vinyl Patient Examination Gloves, Yellow Color

K-Number: K191092 · 2019-07-22

ApplicantAnhui Intco Medical Products Co., Ltd.
Decision Date2019-07-22
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder-Free Vinyl Patient Examination Gloves, Yellow Color is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Intco Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K191092. 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 Powder-Free Vinyl Patient Examination Gloves, Yellow Color?

Powder-Free Vinyl Patient Examination Gloves, Yellow Color is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Anhui Intco Medical Products Co., Ltd.. The 510(k) number is K191092.

When did Powder-Free Vinyl Patient Examination Gloves, Yellow Color receive FDA 510(k) clearance?

Powder-Free Vinyl Patient Examination Gloves, Yellow Color received FDA 510(k) clearance on 2019-07-22, under 510(k) number K191092.

Who is the listed applicant for Powder-Free Vinyl Patient Examination Gloves, Yellow Color?

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

What is the FDA product code for Powder-Free Vinyl Patient Examination Gloves, Yellow Color?

The FDA product code for Powder-Free Vinyl Patient Examination Gloves, Yellow Color is LYZ.

Other records listing Anhui Intco Medical Products 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.

K231365Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam GlovesK233598Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other DrugsK190095Powder-Free Clear Vinyl Patient 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

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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