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FDA 510(k)

VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E

K-Number: K023753 · 2003-03-25

ApplicantArista Latindo Industrial Ltd. P.T
Decision Date2003-03-25
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E is the device name listed in this FDA 510(k) record. The listed applicant is Arista Latindo Industrial Ltd. P.T. It received FDA 510(k) clearance on 2003-03-25 under 510(k) number K023753. 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 EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E?

VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E is a medical device that received FDA 510(k) clearance on 2003-03-25. The listed applicant is Arista Latindo Industrial Ltd. P.T. The 510(k) number is K023753.

When did VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E receive FDA 510(k) clearance?

VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E received FDA 510(k) clearance on 2003-03-25, under 510(k) number K023753.

Who is the listed applicant for VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E?

The FDA 510(k) record lists Arista Latindo Industrial Ltd. P.T as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E?

The FDA product code for VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E is LYZ.

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Other records listing Arista Latindo Industrial Ltd. P.T 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.

K041745VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLORK031944VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLORK031913VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLORK030245NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLORK023754VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN EK023072POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR

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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.

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