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FDA 510(k)

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr

K-Number: K170290 · 2017-05-24

ApplicantShen Wei USA, Inc.
Decision Date2017-05-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr is a medical device manufactured by Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2017-05-24 under approval number K170290. 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 Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr?

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr is a medical device that received FDA 510(k) clearance on 2017-05-24. It is manufactured by Shen Wei USA, Inc.. The 510(k) number is K170290.

When was Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr approved by the FDA?

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr received FDA 510(k) clearance on 2017-05-24, under approval number K170290.

What company makes Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr?

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr is manufactured by Shen Wei USA, Inc..

What is the FDA product code for Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr?

The FDA product code for Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr is LZA.

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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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