(149 days)
The Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
The gloves were tested with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
This FDA 510(k) clearance letter pertains to medical examination gloves and does not describe an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, expert qualifications, ground truth establishment methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.
The document focuses on the performance of a physical medical device (gloves) against specific chemical permeation tests.
Here's the relevant information based on the provided text, focusing on the acceptance criteria and study for the gloves:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is evaluated based on its resistance to permeation by chemotherapy drugs and Fentanyl Citrate. The acceptance criterion is implied by the testing methodology using ASTM D6978-05, aiming for a long breakthrough detection time. While an explicit "acceptance criteria" value isn't stated in the table for each drug, the "Average Breakthrough Detection Time (mins)" provides the reported performance directly. For most drugs, a breakthrough time of "> 240 minutes" is presented, indicating good resistance for at least 4 hours.
| Test drug and concentration | Acceptance Criteria (Implied: High DBT) | Reported Device Performance (Average Breakthrough Detection Time (mins)) |
|---|---|---|
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | High DBT | 13.5 |
| Cisplatin, 1.0 mg/ml (1,000 ppm) | High DBT | > 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) | High DBT | > 240 |
| Dacarbazine, 10.0 mg/ml (10,000 ppm) | High DBT | > 240 |
| Doxorubicin HCL, 2.0 mg/ml (2,000 ppm) | High DBT | > 240 |
| Etoposide, 20.0 mg/ml (20,000 ppm) | High DBT | > 240 |
| Fluorouracil, 50.0 mg/ml (50,000 ppm) | High DBT | > 240 |
| Ifosfamide, 50.0 mg/ml (50,000 ppm) | High DBT | > 240 |
| Methotrexate, 25.0 mg/ml (25,000 ppm) | High DBT | > 240 |
| Mitomycin, 0.5 mg/ml (500 ppm) | High DBT | > 240 |
| Mitoxantrone, 2.0 mg/ml (2,000 ppm) | High DBT | > 240 |
| Paclitaxel, 6.0 mg/ml (6.000 ppm) | High DBT | > 240 |
| ThioTepa, 10.0 mg/ml (10,000 ppm) | High DBT | 19.0 |
| Vincristine Sulfate, 1.0 mg/ml (1,000 ppm) | High DBT | > 240 |
| Fentanyl Citrate Injection, 100 mcg/2ml | High DBT | > 240 |
Note: The cautionary statement "CAUTION: Do not use with Carmustine and ThioTepa" implies that the breakthrough times for these two drugs (13.5 and 19.0 minutes respectively) are considered insufficient for safe use, effectively setting an implicit acceptance criterion that these drugs fail it for prolonged exposure.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set (number of gloves tested per drug). It only refers to a standard test method. The data provenance is not explicitly stated beyond being the result of testing the manufacturer's "Powder-Free Green Biodegradable Nitrile Examination Glove." The testing is prospective for the purpose of this submission. The country of origin of the data is not specified, but the manufacturer is based in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a physical device performance test (chemical permeation), not an AI/ML diagnostic or image interpretation. "Ground truth" in this context is the objective measurement of chemical breakthrough time, typically conducted in a laboratory by trained technicians following a standardized protocol.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a physical device performance test, not involving human interpretation or adjudication in the sense of comparing opinions. The results are quantitative measurements.
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 not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device is the objective measurement of chemical permeation/breakthrough time determined by laboratory testing protocols, specifically ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered device.
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March 10, 2022
Smart Glove Corporation Sdn.Bhd. Lim Keong Deputy General Manager Lot 6487, Batu 5 3/4 Sementa, Jalan Kapar Klang, Selangor 42100 Malaysia
Re: K213373
Trade/Device Name: Powder-Free Green Biodegradable Nitrile Examination Glove 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 Dated: February 14, 2022 Received: February 17, 2022
Dear Lim Keong:
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.
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
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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 (OS) 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 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).
Sincerely,
Clarence W. Murray III, Ph.D. 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) K213373
Device Name
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
The Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
The gloves were tested with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Test drug and concentration | Average Breakthrough Detection Time (mins) |
|---|---|
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | 13.5 |
| Cisplatin, 1.0 mg/ml (1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) | > 240 |
| Dacarbazine, 10.0 mg/ml (10,000 ppm) | > 240 |
| Doxorubicin HCL, 2.0 mg/ml (2,000 ppm) | > 240 |
| Etoposide, 20.0 mg/ml (20,000 ppm) | > 240 |
| Fluorouracil, 50.0 mg/ml (50,000 ppm) | > 240 |
| Ifosfamide, 50.0 mg/ml (50,000 ppm) | > 240 |
| Methotrexate, 25.0 mg/ml (25,000 ppm) | > 240 |
| Mitomycin, 0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone, 2.0 mg/ml (2,000 ppm) | > 240 |
| Paclitaxel, 6.0 mg/ml (6.000 ppm) | > 240 |
| ThioTepa, 10.0 mg/ml (10,000 ppm) | 19.0 |
| Vincristine Sulfate, 1.0 mg/ml (1,000 ppm) | > 240 |
CAUTION: Do not use with Carmustine and ThioTepa.
| Fentanyl Citrate Concentration | Minimum Breakthrough Detection Time (mins) |
|---|---|
| Fentanyl Citrate Injection, 100 mcg/2ml | > 240 |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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.