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FDA 510(k)

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)

K-Number: K171171 · 2018-02-22

ApplicantKoon Seng Sdn Bhd
Decision Date2018-02-22
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) is a medical device manufactured by Koon Seng Sdn Bhd. It received FDA 510(k) clearance on 2018-02-22 under approval number K171171. 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 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)?

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by Koon Seng Sdn Bhd. The 510(k) number is K171171.

When was KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) approved by the FDA?

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) received FDA 510(k) clearance on 2018-02-22, under approval number K171171.

What company makes KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)?

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) is manufactured by Koon Seng Sdn Bhd.

What is the FDA product code for KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)?

The FDA product code for KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) is LZA.

Related Clinical Trials

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

Other Devices by Koon Seng Sdn Bhd

K212613Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)

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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