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FDA 510(k)

Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs

K-Number: K222892 · 2022-12-15

ApplicantGrand Work Plastic Products Co., Ltd.
Decision Date2022-12-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs is a medical device manufactured by Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2022-12-15 under approval number K222892. 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 Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs?

Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-12-15. It is manufactured by Grand Work Plastic Products Co., Ltd.. The 510(k) number is K222892.

When was Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs approved by the FDA?

Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2022-12-15, under approval number K222892.

What company makes Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs?

Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs is manufactured by Grand Work Plastic Products Co., Ltd..

What is the FDA product code for Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs?

The FDA product code for Powder Free Polyurethane Examination Gloves, Blue color, 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 Grand Work Plastic Products Co., Ltd.

K213574Nitrile Vinyl Blend Powder Free Examination Gloves (Black) K220249Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs K220240Vinyl Co-Polymer Powder-free Examination Gloves, Black K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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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

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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