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FDA 510(k)

DISPOSABLE VINYL EXAM GLOVE, POWDERED

K-Number: K113790 · 2012-03-06

ApplicantFull Synergy Medical Products, Inc.
Decision Date2012-03-06
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE VINYL EXAM GLOVE, POWDERED is the device name listed in this FDA 510(k) record. The listed applicant is Full Synergy Medical Products, Inc.. It received FDA 510(k) clearance on 2012-03-06 under 510(k) number K113790. 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 EXAM GLOVE, POWDERED?

DISPOSABLE VINYL EXAM GLOVE, POWDERED is a medical device that received FDA 510(k) clearance on 2012-03-06. The listed applicant is Full Synergy Medical Products, Inc.. The 510(k) number is K113790.

When did DISPOSABLE VINYL EXAM GLOVE, POWDERED receive FDA 510(k) clearance?

DISPOSABLE VINYL EXAM GLOVE, POWDERED received FDA 510(k) clearance on 2012-03-06, under 510(k) number K113790.

Who is the listed applicant for DISPOSABLE VINYL EXAM GLOVE, POWDERED?

The FDA 510(k) record lists Full Synergy Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE VINYL EXAM GLOVE, POWDERED?

The FDA product code for DISPOSABLE VINYL EXAM GLOVE, POWDERED is LYZ.

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Other records listing Full Synergy Medical Products, Inc. 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.

K113749DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLORK113750DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLORK113797DISPOSABLE VINYL EXAM GLOVE, POWDER FREEK113710DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLORK113722DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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