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)

GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE

K-Number: K032011 · 2003-08-19

ApplicantPt. Wrp Buana Multicorpora
Decision Date2003-08-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Wrp Buana Multicorpora. It received FDA 510(k) clearance on 2003-08-19 under 510(k) number K032011. 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 GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE?

GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE is a medical device that received FDA 510(k) clearance on 2003-08-19. The listed applicant is Pt. Wrp Buana Multicorpora. The 510(k) number is K032011.

When did GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE receive FDA 510(k) clearance?

GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE received FDA 510(k) clearance on 2003-08-19, under 510(k) number K032011.

Who is the listed applicant for GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE?

The FDA 510(k) record lists Pt. Wrp Buana Multicorpora as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE?

The FDA product code for GLOVETEX POWDER FREE WHITE NITRILE 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 Pt. Wrp Buana Multicorpora 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.

K032010GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILEK032007GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PRK030273GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILEK022343GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)K994426GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)

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.

↑