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FDA 510(k)

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves

K-Number: K171737 · 2017-12-29

ApplicantAnsell Healthcare Products, LLC
Decision Date2017-12-29
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves is a medical device manufactured by Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2017-12-29 under approval number K171737. 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 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves?

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2017-12-29. It is manufactured by Ansell Healthcare Products, LLC. The 510(k) number is K171737.

When was Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves approved by the FDA?

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves received FDA 510(k) clearance on 2017-12-29, under approval number K171737.

What company makes Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves?

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves is manufactured by Ansell Healthcare Products, LLC.

What is the FDA product code for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves?

The FDA product code for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves 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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