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FDA 510(k)

KIMGUARD ONE-STEP STERILIZATION WRAP

K-Number: K082177 · 2009-03-27

ApplicantKimberly-Clark Corp.
Decision Date2009-03-27
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KIMGUARD ONE-STEP 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 2009-03-27 under 510(k) number K082177. 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 ONE-STEP STERILIZATION WRAP?

KIMGUARD ONE-STEP STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 2009-03-27. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K082177.

When did KIMGUARD ONE-STEP STERILIZATION WRAP receive FDA 510(k) clearance?

KIMGUARD ONE-STEP STERILIZATION WRAP received FDA 510(k) clearance on 2009-03-27, under 510(k) number K082177.

Who is the listed applicant for KIMGUARD ONE-STEP 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 ONE-STEP STERILIZATION WRAP?

The FDA product code for KIMGUARD ONE-STEP STERILIZATION WRAP is FRG.

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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: 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.

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