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FDA 510(k)

POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

K-Number: K100964 · 2010-07-16

ApplicantHebei Shenzichen Plastic & Rubber Products Co., LT
Decision Date2010-07-16
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Shenzichen Plastic & Rubber Products Co., LT. It received FDA 510(k) clearance on 2010-07-16 under 510(k) number K100964. 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 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)?

POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) is a medical device that received FDA 510(k) clearance on 2010-07-16. The listed applicant is Hebei Shenzichen Plastic & Rubber Products Co., LT. The 510(k) number is K100964.

When did POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) receive FDA 510(k) clearance?

POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) received FDA 510(k) clearance on 2010-07-16, under 510(k) number K100964.

Who is the listed applicant for POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)?

The FDA 510(k) record lists Hebei Shenzichen Plastic & Rubber Products Co., LT as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)?

The FDA product code for POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) 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 Hebei Shenzichen Plastic & Rubber Products Co., LT 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.

K100963POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

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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