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FDA 510(k)

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)

K-Number: K222349 · 2022-10-21

ApplicantJr Engineering & Medical Technologies (M) Sdn. Bhd.
Decision Date2022-10-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) is a medical device manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2022-10-21 under approval number K222349. 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 (Orange, Purple)?

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) is a medical device that received FDA 510(k) clearance on 2022-10-21. It is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K222349.

When was JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) approved by the FDA?

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) received FDA 510(k) clearance on 2022-10-21, under approval number K222349.

What company makes JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)?

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

What is the FDA product code for JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)?

The FDA product code for JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) is LZA.

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Related Devices (Code: LZA)

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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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