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FDA 510(k)

VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.)

K-Number: K891567 · 1989-04-11

ApplicantNeo-Sigma, Inc.
Decision Date1989-04-11
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) is the device name listed in this FDA 510(k) record. The listed applicant is Neo-Sigma, Inc.. It received FDA 510(k) clearance on 1989-04-11 under 510(k) number K891567. 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 VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.)?

VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) is a medical device that received FDA 510(k) clearance on 1989-04-11. The listed applicant is Neo-Sigma, Inc.. The 510(k) number is K891567.

When did VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) receive FDA 510(k) clearance?

VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) received FDA 510(k) clearance on 1989-04-11, under 510(k) number K891567.

Who is the listed applicant for VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.)?

The FDA 510(k) record lists Neo-Sigma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.)?

The FDA product code for VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) 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 Neo-Sigma, Inc. 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.

K891841LATEX EXAM GLOVES (MFG. YEOU JIH INDUSTRIAL CO.)K891568VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.)K891566VINYL EXAM GLOVES (MFG. AM GLOVES CO. LTD.)

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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