Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Standard Supreme Sterilization Wrapper

K-Number: K172207 · 2017-08-25

ApplicantStandard Textile Co., Inc.
Decision Date2017-08-25
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Standard Supreme Sterilization Wrapper is a medical device manufactured by Standard Textile Co., Inc.. It received FDA 510(k) clearance on 2017-08-25 under approval number K172207. 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 Standard Supreme Sterilization Wrapper?

Standard Supreme Sterilization Wrapper is a medical device that received FDA 510(k) clearance on 2017-08-25. It is manufactured by Standard Textile Co., Inc.. The 510(k) number is K172207.

When was Standard Supreme Sterilization Wrapper approved by the FDA?

Standard Supreme Sterilization Wrapper received FDA 510(k) clearance on 2017-08-25, under approval number K172207.

What company makes Standard Supreme Sterilization Wrapper?

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

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

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

Other Devices by Standard Textile Co., Inc.

K162162Barrier 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 K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. 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.

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.

↑