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FDA 510(k)

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange

K-Number: K172867 · 2018-05-10

ApplicantGmp Medicare Sdn Bhd (F25)
Decision Date2018-05-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange is a medical device manufactured by Gmp Medicare Sdn Bhd (F25). It received FDA 510(k) clearance on 2018-05-10 under approval number K172867. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange?

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange is a medical device that received FDA 510(k) clearance on 2018-05-10. It is manufactured by Gmp Medicare Sdn Bhd (F25). The 510(k) number is K172867.

When was Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange approved by the FDA?

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange received FDA 510(k) clearance on 2018-05-10, under approval number K172867.

What company makes Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange?

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange is manufactured by Gmp Medicare Sdn Bhd (F25).

What is the FDA product code for Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange?

The FDA product code for Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange is LZA.

Related Clinical Trials

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Other Devices by Gmp Medicare Sdn Bhd (F25)

K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs K182382Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) 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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