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)

POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED

K-Number: K062764 · 2007-02-27

ApplicantKossan Latex Industries(M)Sdn Bhd
Decision Date2007-02-27
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED is the device name listed in this FDA 510(k) record. The listed applicant is Kossan Latex Industries(M)Sdn Bhd. It received FDA 510(k) clearance on 2007-02-27 under 510(k) number K062764. 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 PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED?

POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED is a medical device that received FDA 510(k) clearance on 2007-02-27. The listed applicant is Kossan Latex Industries(M)Sdn Bhd. The 510(k) number is K062764.

When did POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED receive FDA 510(k) clearance?

POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED received FDA 510(k) clearance on 2007-02-27, under 510(k) number K062764.

Who is the listed applicant for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED?

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

What is the FDA product code for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED?

The FDA product code for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED 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.

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 Kossan Latex Industries(M)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.

K123749POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILEK120066POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIALK111772POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILEK062965CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIMK060775POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OFK060771POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED

View all 19 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.

↑