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FDA 510(k)

Vinyl compound examination gloves

K-Number: K211229 · 2021-07-29

ApplicantHebei Titans Hongsen Medical Technology Co., Ltd.
Decision Date2021-07-29
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vinyl compound examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K211229. 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 compound examination gloves?

Vinyl compound examination gloves is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K211229.

When did Vinyl compound examination gloves receive FDA 510(k) clearance?

Vinyl compound examination gloves received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211229.

Who is the listed applicant for Vinyl compound examination gloves?

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

What is the FDA product code for Vinyl compound examination gloves?

The FDA product code for Vinyl compound examination gloves is LYZ.

Other records listing Hebei Titans Hongsen 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.

K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)K223895Disposable Medical Nitrile Examination GlovesK221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)K212097Disposable medical surgical maskK182043Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

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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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