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FDA 510(k)

VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)

K-Number: K903847 · 1991-01-31

ApplicantZest Mark Industrial Co., Ltd.
Decision Date1991-01-31
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD) is the device name listed in this FDA 510(k) record. The listed applicant is Zest Mark Industrial Co., Ltd.. It received FDA 510(k) clearance on 1991-01-31 under 510(k) number K903847. 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 GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)?

VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD) is a medical device that received FDA 510(k) clearance on 1991-01-31. The listed applicant is Zest Mark Industrial Co., Ltd.. The 510(k) number is K903847.

When did VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD) receive FDA 510(k) clearance?

VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD) received FDA 510(k) clearance on 1991-01-31, under 510(k) number K903847.

Who is the listed applicant for VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)?

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

What is the FDA product code for VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)?

The FDA product code for VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD) 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 Zest Mark Industrial 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.

K892793PATIENT EXAMINATION GLOVES (VINYL)K891368PATIENT EXAMINATION GLOVES (LATEX)

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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