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FDA 510(k)

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs

K-Number: K152222 · 2016-04-21

ApplicantGmp Medicare Sdn Bhd (F25)
Decision Date2016-04-21
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Gmp Medicare Sdn Bhd (F25). It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K152222. 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 NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs?

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Gmp Medicare Sdn Bhd (F25). The 510(k) number is K152222.

When did NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs receive FDA 510(k) clearance?

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152222.

Who is the listed applicant for NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs?

The FDA 510(k) record lists Gmp Medicare Sdn Bhd (F25) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs?

The FDA product code for NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs is LZC.

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Other records listing Gmp Medicare Sdn Bhd (F25) 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.

K182382Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, PinkK172867Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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