FDA 510(k)

KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP

K-Number: K881471 · 1988-08-10

Decision Date1988-08-10

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

KIMGUARD (REGULAR & HEAVY DUTY) STERILE 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 1988-08-10 under 510(k) number K881471. 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 (REGULAR & HEAVY DUTY) STERILE WRAP?

KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP is a medical device that received FDA 510(k) clearance on 1988-08-10. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K881471.

When did KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP receive FDA 510(k) clearance?

KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP received FDA 510(k) clearance on 1988-08-10, under 510(k) number K881471.

Who is the listed applicant for KIMGUARD (REGULAR & HEAVY DUTY) STERILE 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 (REGULAR & HEAVY DUTY) STERILE WRAP?

The FDA product code for KIMGUARD (REGULAR & HEAVY DUTY) STERILE 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.