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)

KIMGUARD SMART-FOLD* STERILIZATION WRAP

K-Number: K112300 · 2012-01-19

ApplicantKimberly-Clark Corp.
Decision Date2012-01-19
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KIMGUARD SMART-FOLD* STERILIZATION WRAP 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 2012-01-19 under 510(k) number K112300. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIMGUARD SMART-FOLD* STERILIZATION WRAP?

KIMGUARD SMART-FOLD* STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 2012-01-19. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K112300.

When did KIMGUARD SMART-FOLD* STERILIZATION WRAP receive FDA 510(k) clearance?

KIMGUARD SMART-FOLD* STERILIZATION WRAP received FDA 510(k) clearance on 2012-01-19, under 510(k) number K112300.

Who is the listed applicant for KIMGUARD SMART-FOLD* STERILIZATION WRAP?

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 KIMGUARD SMART-FOLD* STERILIZATION WRAP?

The FDA product code for KIMGUARD SMART-FOLD* STERILIZATION WRAP is FRG.

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 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

View all 102 devices →

Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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.

↑