(227 days)
A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below:
| Carmustine (3.3 mg/ml) | 10.1 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (20 mg/ml) | >240 minutes |
| Dacarbazine (10.1 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes |
| Etoposide (20.0 mg/ml) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes |
| Paclitaxel (6.0 mg/ml) | >240 minutes |
| Thiotepa (10.0 mg/ml) | 30.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
This document is a 510(k) premarket notification letter for a Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs. It explicitly states that the device is a "non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
The key performance aspect highlighted by this document is the glove's resistance to permeation by chemotherapy drugs. The study mentioned is in accordance with ASTM D6978-05, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Here's the breakdown of the requested information based on the provided text, recognizing that this document is an FDA clearance letter and not a full study report, so some details might be absent:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for resistance to chemotherapy drugs are implied by the standard ASTM D6978-05. While the standard itself sets the methodology, typical acceptance criteria for medical gloves exposed to chemotherapy drugs aim for a breakthrough time that is as long as possible, usually exceeding the expected duration of contact or handling. The reported performance is the "breakthrough time" for each drug.
| Chemotherapy Drug | Concentration | Reported Breakthrough Time | Implied Acceptance Criteria (Goal) |
|---|---|---|---|
| Carmustine | 3.3 mg/ml | 10.1 minutes | As long as possible |
| Cisplatin | 1.0 mg/ml | >240 minutes | As long as possible |
| Cyclophosphamide | 20 mg/ml | >240 minutes | As long as possible |
| Dacarbazine | 10.1 mg/ml | >240 minutes | As long as possible |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 minutes | As long as possible |
| Etoposide | 20.0 mg/ml | >240 minutes | As long as possible |
| Fluorouracil | 50.0 mg/ml | >240 minutes | As long as possible |
| Methotrexate | 25 mg/ml | >240 minutes | As long as possible |
| Mitomycin C | 0.5 mg/ml | >240 minutes | As long as possible |
| Paclitaxel | 6.0 mg/ml | >240 minutes | As long as possible |
| Thiotepa | 10.0 mg/ml | 30.4 minutes | As long as possible |
| Vincristine Sulfate | 1.0 mg/ml | >240 minutes | As long as possible |
Note: The ">240 minutes" indicates that no breakthrough was detected within the 240-minute test period, which is a very positive result. The shorter times for Carmustine and Thiotepa indicate that these drugs permeated the glove more quickly than others, but the specific acceptance threshold (e.g., minimum acceptable breakthrough time for each drug) is not stated in this document.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (number of gloves or test replicates) used for testing each chemotherapy drug. It only refers to the general standard, ASTM D6978-05. The data provenance (country of origin, retrospective/prospective) is also not stated. This information would typically be in the full test report, not the FDA clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" for glove permeation is established through a standardized laboratory test (ASTM D6978-05) measuring physical properties, not through expert consensus or interpretation of clinical data. Therefore, no experts in the sense of medical professionals establishing a diagnosis were involved in establishing "ground truth" for this performance characteristic.
4. Adjudication method for the test set
Not applicable. This is a laboratory test measuring a physical property (breakthrough time) using a standardized methodology, not a clinical study requiring adjudication of expert opinions.
5. 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
Not applicable. This device is a physical barrier (glove), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical barrier (glove), not an algorithm or AI system.
7. The type of ground truth used
The ground truth is established by a standardized laboratory measurement according to ASTM D6978-05. This standard describes the specific method for determining the breakthrough time of chemotherapy drugs through medical gloves, using analytical detection methods (e.g., spectrophotometry, chromatography) to identify the permeation of the drug through the glove material.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model. There is no concept of a "training set" for its development or testing in the context of this document.
9. How the ground truth for the training set was established
Not applicable (as above).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2016
Hartalega Sdn. Bhd. Mr. H. Carl Jenkins Regulatory Counsel to Hartalega Sdn. Bhd. 10 E. Scranton Ave. Suite 201 Lake Bluff, IL 60044
Re: K160562
Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 7, 2016 Received: September 9, 2016
Dear Mr. Jenkins:
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. 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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael J. Ryan -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) K160562
Device Name
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below:
| Carmustine (3.3 mg/ml) | 10.1 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (20 mg/ml) | >240 minutes |
| Dacarbazine (10.1 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes |
| Etoposide (20.0 mg/ml) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes |
| Paclitaxel (6.0 mg/ml) | >240 minutes |
| Thiotepa (10.0 mg/ml) | 30.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
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.