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)

SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES

K-Number: K960746 · 1996-06-27

ApplicantSunmax Enterprise Shanghai Co. , Ltd.
Decision Date1996-06-27
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Sunmax Enterprise Shanghai Co. , Ltd.. It received FDA 510(k) clearance on 1996-06-27 under 510(k) number K960746. 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 SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES?

SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES is a medical device that received FDA 510(k) clearance on 1996-06-27. The listed applicant is Sunmax Enterprise Shanghai Co. , Ltd.. The 510(k) number is K960746.

When did SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES receive FDA 510(k) clearance?

SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES received FDA 510(k) clearance on 1996-06-27, under 510(k) number K960746.

Who is the listed applicant for SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES?

The FDA 510(k) record lists Sunmax Enterprise Shanghai Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES?

The FDA product code for SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES 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 Sunmax Enterprise Shanghai 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.

K090336SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGSK011765SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVEK011717SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVESK964964POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

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.

↑