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FDA 510(k)

Barrier Supreme Sterilization Wrapper

K-Number: K162162 · 2016-11-04

ApplicantStandard Textile Co., Inc.
Decision Date2016-11-04
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Barrier Supreme Sterilization Wrapper is a medical device manufactured by Standard Textile Co., Inc.. It received FDA 510(k) clearance on 2016-11-04 under approval number K162162. 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 Barrier Supreme Sterilization Wrapper?

Barrier Supreme Sterilization Wrapper is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Standard Textile Co., Inc.. The 510(k) number is K162162.

When was Barrier Supreme Sterilization Wrapper approved by the FDA?

Barrier Supreme Sterilization Wrapper received FDA 510(k) clearance on 2016-11-04, under approval number K162162.

What company makes Barrier Supreme Sterilization Wrapper?

Barrier Supreme Sterilization Wrapper is manufactured by Standard Textile Co., Inc..

What is the FDA product code for Barrier Supreme Sterilization Wrapper?

The FDA product code for Barrier Supreme Sterilization Wrapper is FRG.

Other Devices by Standard Textile Co., Inc.

K172207Standard Supreme Sterilization Wrapper K241214ProPel SG3™ Surgical Gown

Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, Inc. K152458Gemini Bonded Sterilization WrapMedline Industries, 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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