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FDA 510(k)

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

K-Number: K180476 · 2018-05-15

ApplicantComfort Rubber Gloves Industries Sdn. Bhd.
Decision Date2018-05-15
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 Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2018-05-15 under approval number K180476. 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 2018-05-15. It is manufactured by Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K180476.

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 2018-05-15, under approval number K180476.

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 Comfort Rubber Gloves Industries 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 Comfort Rubber Gloves Industries Sdn. Bhd.

K171541Powder Free Nitrile Examination Gloves (Orange) K162405Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) K190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) K192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl K200181Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K240269Nitrile Powder Free Examination Gloves Biodegradable (Green)

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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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