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FDA 510(k)

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

K-Number: K182043 · 2018-09-21

ApplicantHebei Titans Hongsen Medical Technology Co., Ltd.
Decision Date2018-09-21
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a medical device manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-09-21 under approval number K182043. 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 Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a medical device that received FDA 510(k) clearance on 2018-09-21. It is manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K182043.

When was Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) approved by the FDA?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) received FDA 510(k) clearance on 2018-09-21, under approval number K182043.

What company makes Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd..

What is the FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

The FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is LYZ.

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Related PubMed Literature

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Other Devices by Hebei Titans Hongsen Medical Technology Co., Ltd.

K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs K212097Disposable medical surgical mask K211229Vinyl compound examination gloves K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) K223895Disposable Medical Nitrile Examination Gloves 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)

View all 7 devices →

Related Devices (Code: LYZ)

K162259DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)Zibo Daiyang Plastic Company K161390Vinyl Exam Gloves, Powder Free, ClearZibo Hongchin Plastic and Rubber Co., Ltd. K160675Powder free vinyl patient examination glove, colored (yellow)Kaixing Plastic Products Co., Litd. K160411Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingCardinal Health, Inc. K161072Powder Free Grey Vinyl Examination GlovesZibo Flourish Trading Co., Ltd. K160468Synthetic Vinyl Examination Gloves, Powder-Free, YellowInpro Technology Device Factory

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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