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FDA 510(k)

Xingyu Nitrile Powder Free Patient Examination Gloves, White color

K-Number: K171615 · 2017-07-31

ApplicantShandong Xingyu Gloves Co., Ltd.
Decision Date2017-07-31
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Xingyu Nitrile Powder Free Patient Examination Gloves, White color is a medical device manufactured by Shandong Xingyu Gloves Co., Ltd.. It received FDA 510(k) clearance on 2017-07-31 under approval number K171615. 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 Xingyu Nitrile Powder Free Patient Examination Gloves, White color?

Xingyu Nitrile Powder Free Patient Examination Gloves, White color is a medical device that received FDA 510(k) clearance on 2017-07-31. It is manufactured by Shandong Xingyu Gloves Co., Ltd.. The 510(k) number is K171615.

When was Xingyu Nitrile Powder Free Patient Examination Gloves, White color approved by the FDA?

Xingyu Nitrile Powder Free Patient Examination Gloves, White color received FDA 510(k) clearance on 2017-07-31, under approval number K171615.

What company makes Xingyu Nitrile Powder Free Patient Examination Gloves, White color?

Xingyu Nitrile Powder Free Patient Examination Gloves, White color is manufactured by Shandong Xingyu Gloves Co., Ltd..

What is the FDA product code for Xingyu Nitrile Powder Free Patient Examination Gloves, White color?

The FDA product code for Xingyu Nitrile Powder Free Patient Examination Gloves, White color is LZA.

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Other Devices by Shandong Xingyu Gloves Co., Ltd.

K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color K221272Medical Face Mask K233990Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)

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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