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FDA 510(k)

SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE

K-Number: K031750 · 2003-10-24

ApplicantKimberly-Clark Corp.
Decision Date2003-10-24
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 2003-10-24 under 510(k) number K031750. 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 SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE?

SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE is a medical device that received FDA 510(k) clearance on 2003-10-24. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K031750.

When did SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE receive FDA 510(k) clearance?

SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE received FDA 510(k) clearance on 2003-10-24, under 510(k) number K031750.

Who is the listed applicant for SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE?

The FDA 510(k) record lists Kimberly-Clark Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE?

The FDA product code for SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE is LYZ.

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Other records listing Kimberly-Clark Corp. 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.

K131879KC 300 SURGICAL MASKK131841KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVEK131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBEK120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONINGK112805KIMGUARD ONE-STEP STERILIZATION WRAPK113423KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE

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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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