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)

NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE

K-Number: K984311 · 1999-02-09

ApplicantSumirubber Industries (Kedah) Sdn. Bhd.
Decision Date1999-02-09
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Sumirubber Industries (Kedah) Sdn. Bhd.. It received FDA 510(k) clearance on 1999-02-09 under 510(k) number K984311. 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 NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE?

NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE is a medical device that received FDA 510(k) clearance on 1999-02-09. The listed applicant is Sumirubber Industries (Kedah) Sdn. Bhd.. The 510(k) number is K984311.

When did NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE receive FDA 510(k) clearance?

NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE received FDA 510(k) clearance on 1999-02-09, under 510(k) number K984311.

Who is the listed applicant for NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE?

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

What is the FDA product code for NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE?

The FDA product code for NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sumirubber Industries (Kedah) 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.

K984309NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDEREDK890393EXAMINATION GLOVES

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.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.

↑