(63 days)
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.
Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free. Non-sterile. Ambidextrous. Beaded Cuff. Medical Grade Exam Gloves. Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
This document describes a 510(k) premarket notification for "Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves," which have been "Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)."
Here's an analysis of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for these gloves are defined by their resistance to permeation by specific opioid drugs. The performance is reported as the minimum breakthrough time.
| Test Opioid Drug | Concentration | Acceptance Criteria (Minimum Breakthrough Time) | Reported Device Performance (Minimum Breakthrough Time) |
|---|---|---|---|
| Fentanyl citrate (injectable) | (100mcg/2mL) | >240 minutes | >240 minutes |
| Fentanyl citrate (injectable)+ Heroin | (100mcg/2mL)+ (saturated solution) | >240 minutes | >240 minutes |
| Fentanyl citrate (injectable)+ Heroin in Simulated GastricAcid Mix | (100mcg/2mL)Saturated Solution intosimulated Gastric Acid | >240 minutes | >240 minutes |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (e.g., number of gloves tested) or the provenance (country of origin, retrospective/prospective) of the data for these permeation tests. The information is presented as a summary of the test results rather than a detailed study protocol.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the type of device and study being described. The "ground truth" here is established by standardized chemical permeation testing, not by expert interpretation of medical images or clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. This is a material permeation test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of AI assistance on human reader performance, which is not relevant for testing the chemical resistance of medical gloves.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This concept is not directly applicable. The "device" in question is a physical glove, not an algorithm. The performance described is inherent to the material properties of the glove itself, measured through chemical testing, which is analogous to a "standalone" performance if we think of the glove's material as the "system" being evaluated. No human interpretation is involved in determining the breakthrough time.
7. The Type of Ground Truth Used
The ground truth used is standardized laboratory chemical permeation testing data. This involves precise measurements of the time it takes for specific concentrations of opioid substances to permeate the glove material under controlled conditions, as opposed to expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. These are medical exam gloves, not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above; there is no training set for a physical exam glove. The performance criteria are based on established standards for chemical resistance in protective materials.
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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: K220373
Trade/Device Name: Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam 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, QDO Dated: January 31, 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
K220373
Device Name: Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free. Non-sterile. Ambidextrous. Beaded Cuff. Medical Grade Exam 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 | MinimumBreakthrough Time |
|---|---|---|
| Fentanyl citrate (injectable) | (100mcg/2mL) | >240 minutes |
| Fentanyl citrate (injectable)+ Heroin | (100mcg/2mL)+ (saturated solution) | >240 minutes |
| Fentanyl citrate (injectable)+ Heroin in Simulated GastricAcid Mix | (100mcg/2mL)Saturated Solution intosimulated 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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§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.