Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING

K-Number: K051683 · 2005-08-01

ApplicantShen Wei (Usa), Inc.
Decision Date2005-08-01
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei (Usa), Inc.. It received FDA 510(k) clearance on 2005-08-01 under 510(k) number K051683. 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 POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING?

POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING is a medical device that received FDA 510(k) clearance on 2005-08-01. The listed applicant is Shen Wei (Usa), Inc.. The 510(k) number is K051683.

When did POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING receive FDA 510(k) clearance?

POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING received FDA 510(k) clearance on 2005-08-01, under 510(k) number K051683.

Who is the listed applicant for POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING?

The FDA 510(k) record lists Shen Wei (Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING?

The FDA product code for POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING 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 Shen Wei (Usa), 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.

K213141Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionK213142Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid SolutionK213144Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White ColorsK211620Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)K211455Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White ColorsK202085Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green

View all 58 devices →

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

View on FDA Database →

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

↑