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FDA 510(k)

PRE-POWDERED NITRILE EXAMINATION GLOVES

K-Number: K974442 · 1998-01-05

ApplicantP.T. Latexindo Tobaperkasa
Decision Date1998-01-05
Product CodeLZY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Latexindo Tobaperkasa. It received FDA 510(k) clearance on 1998-01-05 under 510(k) number K974442. The device is classified under product code LZY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-POWDERED NITRILE EXAMINATION GLOVES?

PRE-POWDERED NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1998-01-05. The listed applicant is P.T. Latexindo Tobaperkasa. The 510(k) number is K974442.

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

PRE-POWDERED NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 1998-01-05, under 510(k) number K974442.

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

The FDA 510(k) record lists P.T. Latexindo Tobaperkasa as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for PRE-POWDERED NITRILE EXAMINATION GLOVES is LZY.

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 P.T. Latexindo Tobaperkasa 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.

K974443POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATEDK972539Hi Coat Powder Free Latex Patient Examination Gloves

Related Devices (Code: LZY)

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.

K231448TANDEM Hip SystemSmith & Nephew, Inc.K111145ENDO HEADMedacta InternationalK915528BHR BIPOLAR FEMORAL HEAD COMPONENTImplantology Corp.K915548IONGUARD TITANIUM MODULAR HEADSBiomet, Inc.K903084MODULAR CATHCART FRACTURE SYSTEMDepuy, Inc.K896580UNI-POLAR HEADRichards Medical Co., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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