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FDA 510(k)

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape

K-Number: K191741 · 2019-08-02

ApplicantIntertape Polymer, Inc.
Decision Date2019-08-02
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape is a medical device manufactured by Intertape Polymer, Inc.. It received FDA 510(k) clearance on 2019-08-02 under approval number K191741. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape?

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by Intertape Polymer, Inc.. The 510(k) number is K191741.

When was Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape approved by the FDA?

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape received FDA 510(k) clearance on 2019-08-02, under approval number K191741.

What company makes Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape?

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape is manufactured by Intertape Polymer, Inc..

What is the FDA product code for Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape?

The FDA product code for Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape is JOJ.

Related PubMed Literature

PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025) PMID: 40223422 Cell-Free Biomimetic Tracheal Graft via Hybrid 3D Printing for Enhanced Tracheal Reconstruction. Advanced healthcare materials (2025)

Related Devices (Code: JOJ)

K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeCanadian Technical Tape, Ltd. K160485VERIFY VH2O2 Indicator TapeSTERIS Corporation K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. K172472Micro-MEC 1.8% Glutaraldehyde Monitor StripSTERIS Corporation K170439AN87 DosimeterAndersen Sterilizers, 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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