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FDA 510(k)

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs

K-Number: K182241 · 2019-03-11

ApplicantSri Trang Gloves (Thailand) Co., Ltd.
Decision Date2019-03-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is a medical device manufactured by Sri Trang Gloves (Thailand) Co., Ltd.. It received FDA 510(k) clearance on 2019-03-11 under approval number K182241. 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 Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-03-11. It is manufactured by Sri Trang Gloves (Thailand) Co., Ltd.. The 510(k) number is K182241.

When was Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs approved by the FDA?

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-03-11, under approval number K182241.

What company makes Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is manufactured by Sri Trang Gloves (Thailand) Co., Ltd..

What is the FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

The FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is LZA.

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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 Sri Trang Gloves (Thailand) Co., Ltd.

K182308Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs

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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