(91 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
This document is a 510(k) premarket notification decision letter from the FDA for several types of nitrile examination gloves. It acknowledges the substantial equivalence of the gloves to legally marketed predicate devices.
The acceptance criteria and device performance are related to the gloves' resistance to permeation by chemotherapy drugs and opioid drugs, specifically Fentanyl Citrate and Xylazine HCl. The study conducted appears to be ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold. Instead, it reports the "Minimum Breakthrough Detection Time in Minutes" for various drugs. For the purpose of this analysis, we can infer that a higher breakthrough time (ideally ">240 minutes") is the desired performance. The document explicitly highlights cases where performance is lower than presumably desired.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) - Acceptance (Inferred) | Pink Gloves Performance | Orange Gloves Performance | Blue Gloves Performance | Black Gloves Performance |
|---|---|---|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | High as possible, ideally >240. (Warning: Do Not Use) | 12.4 | 11.7 | 10.1 | 14.4 |
| Cisplatin (1.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Cytarabine (100 mg/ml) | >240 minutes | >240 | Not tested | >240 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Etoposide (20.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Fluorouracil (50.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Ifosfamide (50.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Methotrexate (25.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Mitomycin C (0.5 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Thiotepa (10.0 mg/ml) | High as possible, ideally >240. (Warning: Do Not Use) | 43.1 | 43.2 | 30.2 | 29.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Opioid Drugs | |||||
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Xylazine HCl (100 mg/ml) | >240 minutes | Not Tested | >240 | >240 | >240 |
| Simulated Gastric Acid | >240 minutes | >240 | >240 | >240 | >240 |
Note: For Carmustine (BCNU) and Thiotepa, the warning "Do Not Use with Carmustine (BCNU) and Thiotepa" implies that the reported breakthrough times are considered insufficient for safe use, despite meeting some base level of detection. Thus, the implicit acceptance criterion for these specific drugs is to not use the gloves. For all other drugs where ">240" is reported, this indicates the gloves met or exceeded the 4-hour test duration without breakthrough.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size (number of gloves or trials) used for the permeation tests. It indicates the testing was "as per ASTM D6978-05 (Reapproved 2019) Standard Practice." This ASTM standard would specify the required sample size and methodology.
The data provenance is not explicitly stated in terms of country of origin but is presented as results from a technical study. This would be a prospective test, as the gloves were submitted for testing to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of testing (chemical permeation) does not typically involve human experts establishing ground truth in the way medical imaging or clinical diagnoses do. The "ground truth" is established by the specified ASTM D6978-05 standard methodology, which is an objective chemical permeation test using analytical equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Chemical permeation testing is a laboratory-based, objective measurement, not subject to subjective adjudication by human readers/experts.
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 is a technical performance test for medical gloves, not a study involving human readers or AI in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth is based on objective chemical permeation measurements performed according to ASTM D6978-05 (Reapproved 2019) Standard Practice. This standard defines the method for detecting the breakthrough of specific chemicals through a material.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable for the same reason as point 8.
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November 14, 2023
Kossan International Sdn Bhd Cho Sow Fong Senior Manager Regulatory Affairs Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 3/4, Jalan Kapar Klang, Selangor 42100 Malaysia
Re: K232461
Trade/Device Name: Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO, OPJ Dated: August 11, 2023 Received: August 15, 2023
Dear Cho Sow Fong:
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 (the 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 available 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
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis
Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis
Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | Pink | Orange | Blue | Black |
|---|---|---|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 12.4 | 11.7 | 10.1 | 14.4 | |
| Cisplatin (1.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Cytarabine(100 mg/ml) | >240 | Not tested | >240 | >240 | |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Etoposide (20.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Fluorouracil (50.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Ifosfamide (50.0 mg/ml) | >240 | Not Tested | >240 | >240 | |
| Methotrexate (25.0 mg/ml) | >240 | Not Tested | >240 | >240 | |
| Mitomycin C (0.5 mg/ml) | >240 | Not Tested | >240 | >240 | |
| Mitoxantrone (2.0 mg/ml) | >240 | Not Tested | >240 | >240 | |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Thiotepa (10.0 mg/ml) | 43.1 | 43.2 | 30.2 | 29.2 | |
| Vincristine Sulfate (1.0 mg/ml) | >240 | Not Tested | >240 | >240 |
Please note that Carmustine (BCNU) and Thiotepa has low permeation times.
Warning: Do Not Use with Carmustine (BCNU) and Thiotepa
| Opioid Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |||
|---|---|---|---|---|
| Pink | Orange | Blue | Black | |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 | >240 |
| Xylazine HCl (100 mg/ml) | Not Tested | >240 | >240 | >240 |
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| Simulated Gastric Acid | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| ------------------------ | ------------------------------------------------ |
| Pink | Orange | Blue | Black | |
|---|---|---|---|---|
| Simulated Gastric Acid | >240 | >240 | >240 | >240 |
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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§ 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.