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FDA 510(k)

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

K-Number: K180476 · 2018-05-15

ApplicantComfort Rubber Gloves Industries Sdn. Bhd.
Decision Date2018-05-15
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2018-05-15 under 510(k) number K180476. 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 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-05-15. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K180476.

When did Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-05-15, under 510(k) number K180476.

Who is the listed applicant for Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Comfort Rubber Gloves Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA product code for Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is LZC.

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Other records listing Comfort Rubber Gloves Industries 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.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinK240269Nitrile Powder Free Examination Gloves Biodegradable (Green)K241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis PotentialK192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylK200181Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)

View all 9 devices →

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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