FDA 510(k)

Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs

K-Number: K182089 · 2019-07-30

ApplicantPlatinum Glove Industries Sdn. Bhd.

Decision Date2019-07-30

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs is a medical device manufactured by Platinum Glove Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2019-07-30 under approval number K182089. 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 Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs?

Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-07-30. It is manufactured by Platinum Glove Industries Sdn. Bhd.. The 510(k) number is K182089.

When was Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs approved by the FDA?

Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-07-30, under approval number K182089.

What company makes Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs?

Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs is manufactured by Platinum Glove Industries Sdn. Bhd..

What is the FDA product code for Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs?

The FDA product code for Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.