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FDA 510(k)

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate

K-Number: K221626 · 2022-12-07

ApplicantJr Engineering & Medical Technologies (M) Sdn. Bhd.
Decision Date2022-12-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a medical device manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2022-12-07 under approval number K221626. 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 Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate?

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2022-12-07. It is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K221626.

When was Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate approved by the FDA?

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate received FDA 510(k) clearance on 2022-12-07, under approval number K221626.

What company makes Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate?

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd..

What is the FDA product code for Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate?

The FDA product code for Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate 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 Jr Engineering & Medical Technologies (M) Sdn. Bhd.

K192329Blue Latex Examination Powder Free Gloves K192328JR.MEDIK Latex Surgeon’s Gloves Powder Free K192333Blue Nitrile Examination Gloves Powder Free K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs K222348JR MEDIC K221169JR MEDIC Nitrile Examination Gloves Powder Free- Black

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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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