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FDA 510(k)

JR MEDIC Nitrile Examination Gloves Powder Free- Black

K-Number: K221169 · 2022-10-25

ApplicantJr Engineering & Medical Technologies (M) Sdn. Bhd.
Decision Date2022-10-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JR MEDIC Nitrile Examination Gloves Powder Free- Black is a medical device manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2022-10-25 under approval number K221169. 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 Nitrile Examination Gloves Powder Free- Black?

JR MEDIC Nitrile Examination Gloves Powder Free- Black is a medical device that received FDA 510(k) clearance on 2022-10-25. It is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K221169.

When was JR MEDIC Nitrile Examination Gloves Powder Free- Black approved by the FDA?

JR MEDIC Nitrile Examination Gloves Powder Free- Black received FDA 510(k) clearance on 2022-10-25, under approval number K221169.

What company makes JR MEDIC Nitrile Examination Gloves Powder Free- Black?

JR MEDIC Nitrile Examination Gloves Powder Free- Black is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd..

What is the FDA product code for JR MEDIC Nitrile Examination Gloves Powder Free- Black?

The FDA product code for JR MEDIC Nitrile Examination Gloves Powder Free- Black is LZA.

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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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