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 patient examination glove, Powder Free

K-Number: K153159 · 2016-01-26

ApplicantXingyuan Plastic Products Co., Ltd.
Decision Date2016-01-26
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vinyl patient examination glove, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Xingyuan Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2016-01-26 under 510(k) number K153159. 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 patient examination glove, Powder Free?

Vinyl patient examination glove, Powder Free is a medical device that received FDA 510(k) clearance on 2016-01-26. The listed applicant is Xingyuan Plastic Products Co., Ltd.. The 510(k) number is K153159.

When did Vinyl patient examination glove, Powder Free receive FDA 510(k) clearance?

Vinyl patient examination glove, Powder Free received FDA 510(k) clearance on 2016-01-26, under 510(k) number K153159.

Who is the listed applicant for Vinyl patient examination glove, Powder Free?

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

What is the FDA product code for Vinyl patient examination glove, Powder Free?

The FDA product code for Vinyl patient examination glove, Powder Free 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.

↑