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FDA 510(k)

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs

K-Number: K163146 · 2017-02-13

ApplicantHebei Hongsen Plastics Technology Co, Ltd.
Decision Date2017-02-13
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a medical device manufactured by Hebei Hongsen Plastics Technology Co, Ltd.. It received FDA 510(k) clearance on 2017-02-13 under approval number K163146. 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 Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-02-13. It is manufactured by Hebei Hongsen Plastics Technology Co, Ltd.. The 510(k) number is K163146.

When was POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs approved by the FDA?

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-02-13, under approval number K163146.

What company makes POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is manufactured by Hebei Hongsen Plastics Technology Co, Ltd..

What is the FDA product code for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

The FDA product code for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs 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) 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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