FDA 510(k)

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

K-Number: K172442 · 2017-11-06

Decision Date2017-11-06

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega NGC Sdn. Bhd.. It received FDA 510(k) clearance on 2017-11-06 under 510(k) number K172442. 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 and Tested for Use with Chemotherapy Drugs (Blue)?

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) is a medical device that received FDA 510(k) clearance on 2017-11-06. The listed applicant is Hartalega NGC Sdn. Bhd.. The 510(k) number is K172442.

When did Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) received FDA 510(k) clearance on 2017-11-06, under 510(k) number K172442.

Who is the listed applicant for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)?

The FDA 510(k) record lists Hartalega NGC Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)?

The FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) is LZA.

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Related Devices (Code: LZA)

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company Limited K260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

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.