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FDA 510(k)

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs

K-Number: K173766 · 2018-07-08

ApplicantShen Wei USA, Inc.
Decision Date2018-07-08
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is a medical device manufactured by Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2018-07-08 under approval number K173766. 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 PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is a medical device that received FDA 510(k) clearance on 2018-07-08. It is manufactured by Shen Wei USA, Inc.. The 510(k) number is K173766.

When was PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs approved by the FDA?

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs received FDA 510(k) clearance on 2018-07-08, under approval number K173766.

What company makes PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is manufactured by Shen Wei USA, Inc..

What is the FDA product code for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

The FDA product code for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo 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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