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FDA 510(k)

Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

K-Number: K163017 · 2017-03-22

ApplicantGmp Medicare Sdn. Bhd.
Decision Date2017-03-22
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is a medical device manufactured by Gmp Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2017-03-22 under approval number K163017. 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 Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs?

Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-03-22. It is manufactured by Gmp Medicare Sdn. Bhd.. The 510(k) number is K163017.

When was Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs approved by the FDA?

Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-03-22, under approval number K163017.

What company makes Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs?

Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is manufactured by Gmp Medicare Sdn. Bhd..

What is the FDA product code for Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs?

The FDA product code for Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is LZC.

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Related PubMed Literature

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Other Devices by Gmp Medicare Sdn. Bhd.

K202003Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim K250944Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl

Related Devices (Code: LZC)

K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd 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

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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