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FDA 510(k)

Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color

K-Number: K171422 · 2018-06-11

ApplicantEver Global (Vietnam) Enterprise Corp
Decision Date2018-06-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color is a medical device manufactured by Ever Global (Vietnam) Enterprise Corp. It received FDA 510(k) clearance on 2018-06-11 under approval number K171422. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color?

Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color is a medical device that received FDA 510(k) clearance on 2018-06-11. It is manufactured by Ever Global (Vietnam) Enterprise Corp. The 510(k) number is K171422.

When was Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color approved by the FDA?

Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color received FDA 510(k) clearance on 2018-06-11, under approval number K171422.

What company makes Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color?

Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color is manufactured by Ever Global (Vietnam) Enterprise Corp.

What is the FDA product code for Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color?

The FDA product code for Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color is LZA.

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Other Devices by Ever Global (Vietnam) Enterprise Corp

K170575Disposable Powder Free Vinyl Exam Glove, Clear/Yellow K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

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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