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FDA 510(k)

Biodegradable Nitrile Powder Free Examination Glove (Blue)

K-Number: K173509 · 2018-08-17

ApplicantHartalega Sdn Bhd
Decision Date2018-08-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biodegradable Nitrile Powder Free Examination Glove (Blue) is a medical device manufactured by Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2018-08-17 under approval number K173509. 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 Biodegradable Nitrile Powder Free Examination Glove (Blue)?

Biodegradable Nitrile Powder Free Examination Glove (Blue) is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Hartalega Sdn Bhd. The 510(k) number is K173509.

When was Biodegradable Nitrile Powder Free Examination Glove (Blue) approved by the FDA?

Biodegradable Nitrile Powder Free Examination Glove (Blue) received FDA 510(k) clearance on 2018-08-17, under approval number K173509.

What company makes Biodegradable Nitrile Powder Free Examination Glove (Blue)?

Biodegradable Nitrile Powder Free Examination Glove (Blue) is manufactured by Hartalega Sdn Bhd.

What is the FDA product code for Biodegradable Nitrile Powder Free Examination Glove (Blue)?

The FDA product code for Biodegradable Nitrile Powder Free Examination Glove (Blue) 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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