Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K222349 · 2022-10-21

Decision Date2022-10-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) is the device name listed in this FDA 510(k) record. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) 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. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K222349.

When did JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) receive FDA 510(k) clearance?

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

Who is the listed applicant for JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)?

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Jr Engineering & Medical Technologies (M) Sdn. Bhd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.