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)

Vinyl Exam Gloves, Powder Free, Clear

K-Number: K161390 · 2016-12-19

ApplicantZibo Hongchin Plastic and Rubber Co., Ltd.
Decision Date2016-12-19
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vinyl Exam Gloves, Powder Free, Clear is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Hongchin Plastic and Rubber Co., Ltd.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K161390. 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, Powder Free, Clear?

Vinyl Exam Gloves, Powder Free, Clear is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Zibo Hongchin Plastic and Rubber Co., Ltd.. The 510(k) number is K161390.

When did Vinyl Exam Gloves, Powder Free, Clear receive FDA 510(k) clearance?

Vinyl Exam Gloves, Powder Free, Clear received FDA 510(k) clearance on 2016-12-19, under 510(k) number K161390.

Who is the listed applicant for Vinyl Exam Gloves, Powder Free, Clear?

The FDA 510(k) record lists Zibo Hongchin Plastic and Rubber Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vinyl Exam Gloves, Powder Free, Clear?

The FDA product code for Vinyl Exam Gloves, Powder Free, Clear is LYZ.

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.

↑