Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

K220375 · Summit Glove, Inc. · LZA · Apr 13, 2022 · General Hospital

Device Facts

• Record ID: K220375
• Device Name: Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
• Applicant: Summit Glove, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Apr 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient or victim. This specialty glove has also been tested for use with the Opioid drugs Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid.

Device Story

Intercept Free is a nitrile, powder-free, non-sterile, ambidextrous medical examination glove with textured fingertips and a beaded cuff. Designed for use by healthcare providers or first responders to prevent cross-contamination between examiner and patient/victim. Device provides a barrier against biological contaminants and has been specifically tested for permeation resistance against Fentanyl citrate and Heroin, including mixtures in simulated gastric acid, with breakthrough times exceeding 240 minutes. Used in clinical or field settings; worn on hands.

Clinical Evidence

Bench testing only. Permeation testing performed for Fentanyl citrate (100mcg/2mL), Heroin (saturated solution), and mixtures in simulated gastric acid. All tested conditions demonstrated breakthrough times >240 minutes.

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, textured fingertips, beaded cuff. Non-sterile. Powder-free. Barrier protection principle. No electronic or software components.

Indications for Use

Indicated for use as a disposable patient examination glove to prevent contamination between examiner and patient or victim. Tested for use with Fentanyl citrate, Heroin, and both in simulated gastric acid.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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April 13, 2022

Summit Glove, Inc Wava Truscott President/Consultant Truscott MedSci Associates, LLC 180 Burkemeade Ct. Roswell, Georgia 30075

## Re: K220375

Trade/Device Name: Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove

Regulatory Class: Class I, reserved Product Code: LZA, ODO Dated: February 5, 2022

Received: February 9, 2022

Dear Wava Truscott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K220375

Device Name: Intercept Free, Nitrile Two Toned White/Green, Powder-Free, Textured Fingertips, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

Indications for Use (Describe)

Intended Use: A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient or victim. This specialty glove has also been tested for use with the Opioid drugs Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid.

| Test Opioid Drug | Concentration | Minimum<br>Breakthrough Time |
|----------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------|
| Fentanyl citrate (injectable) | (100mcg/2mL) | >240 minutes |
| Fentanyl citrate (injectable)<br>+ Heroin | (100mcg/2mL)<br>+ (saturated solution) | >240 minutes |
| Fentanyl citrate (injectable)<br>+ Heroin in Simulated Gastric<br>Acid Mix | (100mcg/2mL)<br>Saturated Solution into<br>simulated Gastric Acid | >240 minutes |

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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