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FDA 510(k)

Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs

K-Number: K171378 · 2017-09-14

ApplicantSemperit Investments Asia Pte , Ltd.
Decision Date2017-09-14
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs is a medical device manufactured by Semperit Investments Asia Pte , Ltd.. It received FDA 510(k) clearance on 2017-09-14 under approval number K171378. 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, Single use, Powder-free examination glove tested for use with Chemotherapy drugs?

Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by Semperit Investments Asia Pte , Ltd.. The 510(k) number is K171378.

When was Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs approved by the FDA?

Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs received FDA 510(k) clearance on 2017-09-14, under approval number K171378.

What company makes Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs?

Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs is manufactured by Semperit Investments Asia Pte , Ltd..

What is the FDA product code for Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs?

The FDA product code for Non-Sterile, Single use, Powder-free examination glove 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 Semperit Investments Asia Pte , Ltd.

K160781Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves K183441Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)

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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