FDA 510(k)

QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES

K-Number: K992671 · 1999-09-24

Decision Date1999-09-24

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Latexx Partners Bhd.. It received FDA 510(k) clearance on 1999-09-24 under 510(k) number K992671. 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 QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES?

QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Latexx Partners Bhd.. The 510(k) number is K992671.

When did QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 1999-09-24, under 510(k) number K992671.

Who is the listed applicant for QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES?

The FDA 510(k) record lists Latexx Partners Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES?

The FDA product code for QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Latexx Partners Bhd. as applicant

K011791POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR K011792NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES K992924QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED K991462QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED K981767QTEXX POWDERFREE LATEX EXAMINATION GLOVES K981159PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES

View all 7 devices →

Related Devices (Code: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* 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.