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FDA 510(k)

Powder Free Nitrile Examination Glove

K-Number: K171667 · 2017-09-08

ApplicantProfessional Latex Sdn Bhd
Decision Date2017-09-08
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Glove is a medical device manufactured by Professional Latex Sdn Bhd. It received FDA 510(k) clearance on 2017-09-08 under approval number K171667. 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 Examination Glove?

Powder Free Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2017-09-08. It is manufactured by Professional Latex Sdn Bhd. The 510(k) number is K171667.

When was Powder Free Nitrile Examination Glove approved by the FDA?

Powder Free Nitrile Examination Glove received FDA 510(k) clearance on 2017-09-08, under approval number K171667.

What company makes Powder Free Nitrile Examination Glove?

Powder Free Nitrile Examination Glove is manufactured by Professional Latex Sdn Bhd.

What is the FDA product code for Powder Free Nitrile Examination Glove?

The FDA product code for Powder Free Nitrile Examination Glove is LZA.

Related Clinical Trials

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Other Devices by Professional Latex Sdn Bhd

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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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