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FDA 510(k)

DANTEX VINYL EXAMINATION GLOVES

K-Number: K894488 · 1989-09-26

ApplicantDan Co., Ltd.
Decision Date1989-09-26
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DANTEX VINYL EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Dan Co., Ltd.. It received FDA 510(k) clearance on 1989-09-26 under 510(k) number K894488. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANTEX VINYL EXAMINATION GLOVES?

DANTEX VINYL EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is Dan Co., Ltd.. The 510(k) number is K894488.

When did DANTEX VINYL EXAMINATION GLOVES receive FDA 510(k) clearance?

DANTEX VINYL EXAMINATION GLOVES received FDA 510(k) clearance on 1989-09-26, under 510(k) number K894488.

Who is the listed applicant for DANTEX VINYL EXAMINATION GLOVES?

The FDA 510(k) record lists Dan Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DANTEX VINYL EXAMINATION GLOVES?

The FDA product code for DANTEX VINYL EXAMINATION GLOVES is LYZ.

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 Dan Co., Ltd. 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.

K896527POWDER-FREE DANTEX VINYL EXAMINATION GLOVESK890816PATIENT EXAMINATION GLOVES

Related Devices (Code: LYZ)

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.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

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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