Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs

K-Number: K161187 · 2016-09-09

ApplicantEco Medi Glove Sdn. Bhd.
Decision Date2016-09-09
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K161187. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs?

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K161187.

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

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161187.

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

The FDA 510(k) record lists Eco Medi Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs is LZA.

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.

NCT07294131Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.RECRUITINGNCT07546279The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.RECRUITINGNCT01143558Searching for Persistence of Infection in Lyme DiseaseCOMPLETEDNCT06245603A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder CancerRECRUITINGNCT06823440Prevention of CIPN Using Compressive TherapyRECRUITING

Other records listing Eco Medi Glove 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.

K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric AcidK232764Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimK220943Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test ClaimK202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable ProteinK193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims

View all 11 devices →

Related Devices (Code: LZA)

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.

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company LimitedK260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

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.

↑