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)

SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE

K-Number: K993680 · 1999-12-13

ApplicantTop Glove Sdn. Bhd.
Decision Date1999-12-13
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Top Glove Sdn. Bhd.. It received FDA 510(k) clearance on 1999-12-13 under 510(k) number K993680. 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 SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE?

SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE is a medical device that received FDA 510(k) clearance on 1999-12-13. The listed applicant is Top Glove Sdn. Bhd.. The 510(k) number is K993680.

When did SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE receive FDA 510(k) clearance?

SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE received FDA 510(k) clearance on 1999-12-13, under 510(k) number K993680.

Who is the listed applicant for SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE?

The FDA 510(k) record lists Top Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE?

The FDA product code for SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE 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 Top Glove Sdn. Bhd. 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.

K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimK192111Biodegradable Nitrile Examination Powder Free Glove, GreenK193150Latex Examination Powder Free Glove, Aloe VeraK172923Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, BlueK171279Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free GlovesK122999POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

View all 18 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.

↑