FDA 510(k)

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)

K-Number: K192232 · 2019-11-08

Decision Date2019-11-08

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) is a medical device manufactured by Hartalega NGC Sdn. Bhd.. It received FDA 510(k) clearance on 2019-11-08 under approval number K192232. 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 Powder Free Examination Glove with Low Dermatitis Potential Claim (White)?

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by Hartalega NGC Sdn. Bhd.. The 510(k) number is K192232.

When was Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) approved by the FDA?

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) received FDA 510(k) clearance on 2019-11-08, under approval number K192232.

What company makes Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)?

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) is manufactured by Hartalega NGC Sdn. Bhd..

What is the FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)?

The FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) is LZA.

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Other Devices by Hartalega NGC Sdn. Bhd.

K151997Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) K172442Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) K170794Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) K162646Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) K162923NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE K190454Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.