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FDA 510(k)

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs

K-Number: K173766 · 2018-07-08

ApplicantShen Wei USA, Inc.
Decision Date2018-07-08
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2018-07-08 under 510(k) number K173766. 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 PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is a medical device that received FDA 510(k) clearance on 2018-07-08. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K173766.

When did PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs receive FDA 510(k) clearance?

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs received FDA 510(k) clearance on 2018-07-08, under 510(k) number K173766.

Who is the listed applicant for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

The FDA product code for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is LZC.

Related Clinical Trials

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.

NCT05857969Ex Vivo Drug Sensitivity Testing and Multi-Omics ProfilingRECRUITING

Other records listing Shen Wei USA, Inc. 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.

K213141Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionK213142Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid SolutionK213144Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White ColorsK211620Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)K211455Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White ColorsK202085Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green

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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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