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FDA 510(k)

KIMBERLY-CLARK CHILD'S FACEMASK

K-Number: K113340 · 2012-05-04

ApplicantKimberly-Clark
Decision Date2012-05-04
Product CodeOXZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KIMBERLY-CLARK CHILD'S FACEMASK is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark. It received FDA 510(k) clearance on 2012-05-04 under 510(k) number K113340. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIMBERLY-CLARK CHILD'S FACEMASK?

KIMBERLY-CLARK CHILD'S FACEMASK is a medical device that received FDA 510(k) clearance on 2012-05-04. The listed applicant is Kimberly-Clark. The 510(k) number is K113340.

When did KIMBERLY-CLARK CHILD'S FACEMASK receive FDA 510(k) clearance?

KIMBERLY-CLARK CHILD'S FACEMASK received FDA 510(k) clearance on 2012-05-04, under 510(k) number K113340.

Who is the listed applicant for KIMBERLY-CLARK CHILD'S FACEMASK?

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

What is the FDA product code for KIMBERLY-CLARK CHILD'S FACEMASK?

The FDA product code for KIMBERLY-CLARK CHILD'S FACEMASK is OXZ.

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.

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Other records listing Kimberly-Clark 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.

K112562BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETERK111402KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODELK103150KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASKK101596KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-

Related Devices (Code: OXZ)

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.

K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.K210321Dukal Corporation Level 1 Pediatric Face MaskDukal CorporationK201514Child Face MaskShandong Shengquan New Material Co., Ltd.K202831The iMask Child's Face MaskPac-Dent, Inc.K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)Amd Medicom, Inc.

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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