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)

Disposable Vinyl Examination Gloves

K-Number: K203439 · 2021-02-26

ApplicantShandong Zhushi Pharmaceutical Group Co., Ltd.
Decision Date2021-02-26
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Vinyl Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K203439. 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 Disposable Vinyl Examination Gloves?

Disposable Vinyl Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K203439.

When did Disposable Vinyl Examination Gloves receive FDA 510(k) clearance?

Disposable Vinyl Examination Gloves received FDA 510(k) clearance on 2021-02-26, under 510(k) number K203439.

Who is the listed applicant for Disposable Vinyl Examination Gloves?

The FDA 510(k) record lists Shandong Zhushi Pharmaceutical Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Vinyl Examination Gloves?

The FDA product code for Disposable Vinyl Examination Gloves is LYZ.

Other records listing Shandong Zhushi Pharmaceutical Group 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.

K232475Disposable infusion set with needleK212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needleK210510Disposable Surgical GownK210643Disposable Surgical Face MaskK210409Disposable Surgical Face MaskK203454Infrared Thermometer

View all 8 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.

↑