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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 a medical device manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2021-12-06 under approval 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. It is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K212827.

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

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

What company makes 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 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?

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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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 K221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate K222348JR MEDIC K221169JR MEDIC Nitrile Examination Gloves Powder Free- Black

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Related Devices (Code: LZC)

K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsGmp Medicare Sdn Bhd (F25) K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTCareplus (M) 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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