(265 days)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent containation between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
The document describes a medical device called "Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs" and its clearance for marketing. The acceptance criteria and the study proving the device meets these criteria are specifically related to the gloves' permeation resistance to various chemotherapy drugs.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The implicit acceptance criterion for gloves tested with chemotherapy drugs is to demonstrate a reasonable "Breakthrough Detection Time," meaning the time it takes for the chemotherapy drug to permeate through the glove material. While not explicitly stated as a pass/fail threshold in the provided text, the standard practice in evaluating such gloves is typically referenced against established guidelines (e.g., ASTM standards for barrier protection). The performance reported is the actual breakthrough detection time for each drug.
| Chemotherapy Drugs: | Acceptance Criteria (Implied) | White Glove Reported Performance (Breakthrough Detection Time) | Blue Glove Reported Performance (Breakthrough Detection Time) |
|---|---|---|---|
| 1. Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | High breakthrough time | 79.0 min | 48.5 min |
| 2. Cisplatin 1.0 mg/ml (1,000 ppm) | High breakthrough time | >240 min | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml (20,000ppm) | High breakthrough time | >240 min | >240 min |
| 4. Dacarbazine (DTIC) 10.0 mg/ml (10,000ppm) | High breakthrough time | >240 min | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | High breakthrough time | >240 min | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | High breakthrough time | >240 min | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | High breakthrough time | >240 min | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | High breakthrough time | >240 min | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | High breakthrough time | >240 min | >240 min |
| 10. Mitomycin C 0.5 mg/ml (500ppm) | High breakthrough time | >240 min | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | High breakthrough time | >240 min | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | High breakthrough time | >240 min | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | High breakthrough time | 79.2 min | 169.4 min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | High breakthrough time | >240 min | >240 min |
Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes." This indicates that while higher numbers are generally better, specific breakthrough times are reported and acknowledged. The "acceptance criteria" here is simply the demonstration and reporting of these values to show the glove's performance against specific drugs, allowing users to make informed decisions.
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample size used for testing each glove type with each chemotherapy drug. The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it's a 510(k) submission to the FDA, it implies that the testing was conducted in a controlled, prospective manner to meet regulatory requirements, likely in a laboratory setting adhering to recognized standards (e.g., ASTM D6978).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is not applicable (N/A) to the clearance of surgical gloves for chemotherapy drug permeation. The "ground truth" here is objective scientific measurement (breakthrough detection time) determined through laboratory testing, not subjective expert assessment as would be the case for image interpretation or diagnostic accuracy.
4. Adjudication Method for the Test Set:
This is N/A. Since the "ground truth" is established by objective laboratory measurements, there is no need for expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
This is N/A. Surgical gloves are not diagnostic devices that involve "readers" or "cases" in the context of comparative effectiveness studies against AI. The document focuses on the material's barrier properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is N/A. The device is a physical product (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth used is objective laboratory measurement of Breakthrough Detection Time obtained through standardized chemical permeation testing (e.g., following a standard like ASTM D6978), which measures the time it takes for a chemotherapy drug to permeate through the glove material.
8. The Sample Size for the Training Set:
This is N/A. The device is a physical product, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This is N/A for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 9, 2019
Smart Glove Corporation Sdn.Bhd. Khon Foo Managing Director Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar Klang, 42100 My
Re: K181047
Trade/Device Name: Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: November 29, 2018 Received: December 3, 2018
Dear Khon Foo:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181047
Device Name
Powder Free White , Blue Sterilized Nitrile Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
Indications for Use (Describe)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent containation between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Chemotherapy Drug permeation and concentration ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves.
| Chemotherapy Drugs: | Breakthrough Detection Time in Minutes | |
|---|---|---|
| White Glove | Blue Glove | |
| 1. Carmustine ( BCNU)3.3 mg/ml(3,300 ppm) | 79.0 min | 48.5 min |
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | >240 min | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) | >240 min | >240 min |
| 4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) | >240 min | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | >240 min | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | >240 min | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | >240 min | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | >240 min | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | >240 min | >240 min |
| 10.Mitomycin C 0.5 mg/ml (500ppm) | >240 min | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | >240 min | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | >240 min | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | 79.2 min | 169.4 min |
| 14.Vincristine Sulfate 1.0 mg/ml (1,000ppm) | >240 min | >240 min |
Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes .
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)
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§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).