FDA 510(k)

GUARDIAN STERILIZATION WRAP

K-Number: K803294 · 1981-02-02

Decision Date1981-02-02

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

GUARDIAN 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 1981-02-02 under 510(k) number K803294. 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 GUARDIAN STERILIZATION WRAP?

GUARDIAN STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 1981-02-02. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K803294.

When did GUARDIAN STERILIZATION WRAP receive FDA 510(k) clearance?

GUARDIAN STERILIZATION WRAP received FDA 510(k) clearance on 1981-02-02, under 510(k) number K803294.

Who is the listed applicant for GUARDIAN 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 GUARDIAN STERILIZATION WRAP?

The FDA product code for GUARDIAN STERILIZATION WRAP is FRG.

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Other records listing Kimberly-Clark Corp. as applicant

K131879KC 300 SURGICAL MASK K131841KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE K131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE K120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING K112805KIMGUARD ONE-STEP STERILIZATION WRAP K113423KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE

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Related Devices (Code: FRG)

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, LLC K253454HALYARD* 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.