(59 days)
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with Chemotherapy Drugs and the Opioid Fentanyl citrate, simulated Gastric Acid and Fentanyl in Gastric Acid.
Powder Free Nitrile Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
The provided text describes the indications for use and performance of Powder Free Nitrile Examination Gloves, specifically tested for chemotherapy drugs and fentanyl. This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study report that would typically detail acceptance criteria and a study design for a new device's performance.
Therefore, the information required to fully answer your request regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in this document. This document primarily presents the results of testing the gloves against various substances.
However, I can extract the reported device performance from the provided tables, which can be interpreted as demonstrating that the device met certain performance criteria for breakthrough detection times. The implicit acceptance criterion for most of the listed substances appears to be "no breakthrough up to 240 minutes."
Here's a breakdown based on the available information:
1. Table of acceptance criteria and the reported device performance
| Chemo/Opioid Drug | Concentration Tested | Implicit Acceptance Criterion (Maximum Breakthrough Detection Time) | Reported Device Performance (Minimum Breakthrough Detection Time) |
|---|---|---|---|
| Carboplatin | 10.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Carmustine (BCNU) | 3.3mg/ml | Not met (Explicit warning provided) | 23.6 minutes |
| Cisplatin | 10.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Cytarabine HCL | 100.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Dacarbazine (DTIC) | 10.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Docetaxel | 10.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Doxorubicin Hydrochloride | 2.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Etoposide (Toposar) | 20.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Fluorouracil | 50.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Gemcitabine | 38.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Ifosfamide | 50.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Irinotecan | 20.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Mechlorethamine | 1.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Melphalan | 5.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Methotrexate | 25.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Mitomycin C | 0.5mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Mitoxantrone | 2.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Paclitaxel (Taxol) | 6.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| ThioTepa | 10.0mg/ml | Not met (Explicit warning provided) | 57.8 minutes |
| Vincristine Sulfate | 1.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Fentanyl citrate (injectable) | 100mg/2ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Gastric Acid (simulated) | 0.2%NaCl in 0.7 HCL | >= 240 minutes | No breakthrough up to 240 minutes |
| Fentanyl in Gastric Acid | 50/50 mix | >= 240 minutes | No breakthrough up to 240 minutes |
Note: The acceptance criterion of "No breakthrough up to 240 minutes" is inferred from the reported performance for most substances. For Carmustine and ThioTepa, the low breakthrough times are explicitly called out as a warning, indicating they do not meet the implied 240-minute resistance for other drugs/substances.
The following information is NOT available in the provided document:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not specify the number of gloves tested for each substance or the origin/type of data collection. This is typical for a 510(k) summary, which often references testing standards (e.g., ASTM standards for glove permeability) rather than detailing the full study protocol.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A, as this is a physical barrier test, not an assessment requiring expert interpretation of complex data (like medical imaging). The "ground truth" would be the chemical breakthrough itself, detected by analytical methods.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is not an AI or diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" is the objective measurement of chemical breakthrough time, typically determined by standardized laboratory methods (e.g., in accordance with ASTM D6978 for chemotherapy drugs).
- The sample size for the training set: N/A. There is no AI or machine learning component that would require a training set.
- How the ground truth for the training set was established: N/A.
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March 26, 2022
KSG MEDICARE Sdn. Bhd. % Wava Truscott President Truscott MedSci Associates, LLC 180 Burkemeade Ct. Roswell, Georgia 30075
Re: K220215
Trade/Device Name: Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: January 23, 2022 Received: January 26, 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); 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) K220215
Device Name
Powder Free Nitrile Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
Indications for Use (Describe)
Intended for use: A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with Chemotherapy Drugs and the Opioid Fentanyl citrate, simulated Gastric Acid and Fentanyl in Gastric Acid.
| Chemotherapy Drug | ConcentrationTested | MinimumBreakthrough Detection Time |
|---|---|---|
| Carboplatin | 10.0mg/ml | No breakthrough up to 240 minutes |
| Carmustine (BCNU) | 3.3mg/ml | 23.6 minutes |
| Cisplatin | 10.0mg/ml | No breakthrough up to 240 minutes |
| Cytarabine HCL | 100.0mg/ml | No breakthrough up to 240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | No breakthrough up to 240 minutes |
| Dacarbazine (DTIC) | 10.0mg/ml | No breakthrough up to 240 minutes |
| Docetaxel | 10.0mg/ml | No breakthrough up to 240 minutes |
| Doxorubicin Hydrochloride | 2.0mg/ml | No breakthrough up to 240 minutes |
| Etoposide (Toposar) | 20.0mg/ml | No breakthrough up to 240 minutes |
| Fluorouracil | 50.0mg/ml | No breakthrough up to 240 minutes |
| Gemcitabine | 38.0mg/ml | No breakthrough up to 240 minutes |
| Ifosfamide | 50.0mg/ml | No breakthrough up to 240 minutes |
| Irinotecan | 20.0mg/ml | No breakthrough up to 240 minutes |
| Mechlorethamine | 1.0mg/ml | No breakthrough up to 240 minutes |
| Melphalan | 5.0mg/ml | No breakthrough up to 240 minutes |
| Methotrexate | 25.0mg/ml | No breakthrough up to 240 minutes |
| Mitomycin C | 0.5mg/ml | No breakthrough up to 240 minutes |
| Mitoxantrone | 2.0mg/ml | No breakthrough up to 240 minutes |
| Paclitaxel (Taxol) | 6.0mg/ml | No breakthrough up to 240 minutes |
| ThioTepa | 10.0mg/ml | 57.8 minutes |
| Vincristine Sulfate | 1.0mg/ml | No breakthrough up to 240 minutes |
Important: Carmustine and ThioTepa have extremely low minimal breakthrough times of 23.6 minutes and 57.8 minutes respectively. Warning: Do not use with Carmustine or ThioTepa
| Opioid Drug | ConcentrationTested | Minimum Breakthrough DetectionTime |
|---|---|---|
| Fentanyl citrate (injectable) | 100mg/2ml | No breakthrough up to 240 minutes |
| Gastric Acid (simulated) | 0.2%NaCl in 0.7 HCL | No breakthrough up to 240 minutes |
| Fentanyl in Gastric Acid | 50/50 mix | No breakthrough up to 240 minutes |
Please Note: Gloves used for protection against possible Chemotherapy Drug exposure should be selected specifically for the type of drugs used. Users should review the drug labeling or material data sheets for the drug being used to determine an adequate level of protection.
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| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D)☒Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | ☒ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☒ 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.