(252 days)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|---|
| * Carmustine (BCNU) (3.3 mg/ml) | 27.3 | |
| Cisplatin (1.0 mg/ml) | > 240 | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | |
| Dacarbazine (10.0 mg/ml) | > 240 | |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 | |
| Etoposide (20.0 mg/ml) | > 240 | |
| Fluorouracil (50.0 mg/ml) | > 240 | |
| Ifosfamide (50.0 mg/ml) | > 240 | |
| Methotrexate (25.0 mg/ml) | > 240 | |
| Mitomycin C (0.5 mg/ml) | > 240 | |
| Mitoxantrone (2.0 mg/ml) | > 240 | |
| Paclitaxel (6.0 mg/ml) | > 240 | |
| * ThioTepa (10.0 mg/ml) | 26.9 | |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
*WARNING: Do not use Carmustine and ThioTepa.
Not Found
This document is a 510(k) premarket notification for a medical device, specifically Powder Free Nitrile Surgical Glove, Sterile, Tested For Use With Chemotherapy Drugs. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested details about acceptance criteria, test sets, experts, and ground truth are not directly applicable to a 510(k) submission for a non-AI/ML medical device like a surgical glove.
However, based on the provided text, we can extract information regarding the device's performance against specific standards:
1. A table of acceptance criteria and the reported device performance.
The acceptance criteria here are implicitly defined by the ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is presented in the table provided in the "Indications for Use" section. For most drugs, the performance exceeds 240 minutes, with the notable exception of Carmustine and ThioTepa.
| Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard and "good" performance for others) | Reported Device Performance (Average Breakthrough Detection Time (Minutes)) | Comments |
|---|---|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | --- | > 240 minutes (ideal, based on other drugs) | 27.3 | WARNING: Do not use |
| Cisplatin (1.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Dacarbazine (10.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Doxorubicin Hydrochloride (2.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Etoposide (20.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Fluorouracil (50.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Ifosfamide (50.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Methotrexate (25.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Mitomycin C (0.5 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Mitoxantrone (2.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Paclitaxel (6.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| ThioTepa (10.0 mg/ml) | --- | > 240 minutes (ideal, based on other drugs) | 26.9 | WARNING: Do not use |
| Vincristine Sulfate (1.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
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 specify the sample size for the testing of the chemotherapy drug permeation. It is a standard test defined by ASTM D6978, which would outline the appropriate sample size. The provenance of the data (country of origin, retrospective/prospective) is not mentioned. This testing is typically prospective, performed on newly manufactured batches of gloves.
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)
This question is not applicable. The "ground truth" here is the measured breakthrough time of chemotherapy drugs through the glove material, determined by laboratory testing according to ASTM D6978. It does not involve expert medical opinion or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used when human judgment is involved in establishing a ground truth, such as in clinical studies with expert readers. Here, the "truth" is an objective measurement from a standardized test.
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
This question is not applicable. This document is for a physical medical device (surgical gloves) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This document is for a physical medical device (surgical gloves) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used is objective measurement based on a standardized laboratory test (ASTM D6978). The breakthrough detection time is a direct measurement of how long it takes for a chemotherapy drug to permeate through the glove material.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of testing the performance of a physical device like a surgical glove against a standardized permeation test.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set mentioned in this context.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
June 11, 2021
Wrp Asia Pacific Sdn Bhd % Saravanan Ramasamy Head of QA/RA Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang, Selangor Darul Ehsan Malaysia
Re: K203030
Trade/Device Name: Powder Free Nitrile Surgical Glove, Sterile, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: March 3, 2021 Received: March 17, 2021
Dear Saravanan Ramasamy:
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).
Sincerelv.
Ryan Ortega -S
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203030
Device Name
POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Indications for Use (Describe)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|---|
| * Carmustine (BCNU) (3.3 mg/ml) | 27.3 | |
| Cisplatin (1.0 mg/ml) | > 240 | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | |
| Dacarbazine (10.0 mg/ml) | > 240 | |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 | |
| Etoposide (20.0 mg/ml) | > 240 | |
| Fluorouracil (50.0 mg/ml) | > 240 | |
| Ifosfamide (50.0 mg/ml) | > 240 | |
| Methotrexate (25.0 mg/ml) | > 240 | |
| Mitomycin C (0.5 mg/ml) | > 240 | |
| Mitoxantrone (2.0 mg/ml) | > 240 | |
| Paclitaxel (6.0 mg/ml) | > 240 | |
| * ThioTepa (10.0 mg/ml) | 26.9 | |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
*WARNING: Do not use Carmustine and ThioTepa.
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)
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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).