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FDA 510(k)

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs

K-Number: K151390 · 2016-05-02

ApplicantMaxter Glove Manufacturing Sdn Bhd
Decision Date2016-05-02
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs is a medical device manufactured by Maxter Glove Manufacturing Sdn Bhd. It received FDA 510(k) clearance on 2016-05-02 under approval number K151390. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs?

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2016-05-02. It is manufactured by Maxter Glove Manufacturing Sdn Bhd. The 510(k) number is K151390.

When was Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs approved by the FDA?

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs received FDA 510(k) clearance on 2016-05-02, under approval number K151390.

What company makes Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs?

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs is manufactured by Maxter Glove Manufacturing Sdn Bhd.

What is the FDA product code for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs?

The FDA product code for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs is LZC.

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Related PubMed Literature

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Other Devices by Maxter Glove Manufacturing Sdn Bhd

K172864Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

Related Devices (Code: LZC)

K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsGmp Medicare Sdn Bhd (F25) K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTCareplus (M) Sdn Bhd K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIMBrightway Holdings 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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