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FDA 510(k)

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

K-Number: K212827 · 2021-12-06

ApplicantJr Engineering & Medical Technologies (M) Sdn. Bhd.
Decision Date2021-12-06
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs 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 2021-12-06 under 510(k) number K212827. The device is classified under product code LZC. 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?

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a medical device that received FDA 510(k) clearance on 2021-12-06. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K212827.

When did Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs receive FDA 510(k) clearance?

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs received FDA 510(k) clearance on 2021-12-06, under 510(k) number K212827.

Who is the listed applicant for Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs?

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 Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs?

The FDA product code for Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is LZC.

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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.

K222350Sterile Nitrile Surgical Gloves Powder FreeK221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl CitrateK222348JR MEDICK221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackK222349JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)K221157JR Medic

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Related Devices (Code: LZC)

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.

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

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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