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FDA 510(k)

Orange Non Sterile Powder Free Nitrile Examination Gloves

K-Number: K172642 · 2017-11-28

ApplicantCentral Medicare Sdn Bhd
Decision Date2017-11-28
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Orange Non Sterile Powder Free Nitrile Examination Gloves is a medical device manufactured by Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2017-11-28 under approval number K172642. 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 Orange Non Sterile Powder Free Nitrile Examination Gloves?

Orange Non Sterile Powder Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2017-11-28. It is manufactured by Central Medicare Sdn Bhd. The 510(k) number is K172642.

When was Orange Non Sterile Powder Free Nitrile Examination Gloves approved by the FDA?

Orange Non Sterile Powder Free Nitrile Examination Gloves received FDA 510(k) clearance on 2017-11-28, under approval number K172642.

What company makes Orange Non Sterile Powder Free Nitrile Examination Gloves?

Orange Non Sterile Powder Free Nitrile Examination Gloves is manufactured by Central Medicare Sdn Bhd.

What is the FDA product code for Orange Non Sterile Powder Free Nitrile Examination Gloves?

The FDA product code for Orange Non Sterile Powder Free Nitrile Examination Gloves is LZC.

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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) 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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