(192 days)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
This surgeon's glove is a device made of synthetic rubber.
The provided text is a 510(k) premarket notification for "Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs." This submission focuses on the performance of surgical gloves in resisting permeation by chemotherapy drugs.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the "Breakthrough Detection Time" specifications for various chemotherapy drugs. The reported device performance is the actual breakthrough time measured for each drug.
| Test Chemotherapy Drug and Concentration | Acceptance Criteria (Breakthrough Detection Time - Minutes) | Reported Device Performance (Minutes) |
|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | Implied: Minimum acceptable time | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | Implied: Minimum acceptable time | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20.000 ppm) | Implied: Minimum acceptable time | >240 min |
| Fluorouracil 50.0 mg/ml (50.000 ppm) | Implied: Minimum acceptable time | >240 min |
| Ifosfamide 50.0 mg/ml (50.000 ppm) | Implied: Minimum acceptable time | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | Implied: Minimum acceptable time | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | Implied: Minimum acceptable time | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | Implied: Minimum acceptable time | >240 min |
Note on Acceptance Criteria: The document directly presents the performance data rather than explicit numerical acceptance criteria for each drug from a regulatory body. However, for devices of this nature, the general "acceptance" is that the glove performs adequately for its intended use, typically implying that longer breakthrough times are better. The explicit mention of Carmustine and ThioTEPA's breakthrough times as a "Caution" implies that their performance, while reported, is at the lower end of the acceptable spectrum compared to the others that exceed 240 minutes.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size (number of gloves or tests performed for each drug). For Carmustine and Thiotepa, three individual values are listed in parentheses (e.g., 47.8, 38.3, 37.5 for Carmustine), suggesting at least three tests were performed for these specific drugs, and an average was calculated. For other drugs, only ">240 min" is reported, so the exact number of tests is not discernible from the text.
- Data Provenance: Not specified in the document. It's likely from laboratory testing conducted by or for the manufacturer (Pt. Medisafe Technologies) to assess the glove's barrier properties against chemotherapy drugs. The country of origin of the data is not mentioned, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of testing (chemotherapy drug permeation) does not typically involve human experts to establish "ground truth." The ground truth is established through standardized laboratory testing methods that measure the chemical permeation. Therefore, information about experts and their qualifications in this context is not applicable. The "ground truth" for permeation resistance is determined by the output of the testing apparatus using recognized analytical techniques.
4. Adjudication Method for the Test Set
Not applicable. As this is chemical permeation testing, there is no expert adjudication process in the traditional sense. The results are derived directly from the laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an imaging or diagnostic device that involves human readers interpreting cases. It's a medical device (surgical glove) whose performance is evaluated through material science and chemical permeation tests, not through human interpretation or comparative effectiveness studies with AI assistance.
6. Standalone Performance
Yes, the study describes the standalone (algorithm or device-only) performance. The reported breakthrough detection times are purely reflective of the glove's material properties and its resistance to chemical permeation, without any human-in-the-loop interaction during the performance measurement.
7. Type of Ground Truth Used
The ground truth used is laboratory measurement/chemical assay results. Specifically, it's the time until a chemotherapy drug is detected on the inner surface of the glove, as determined by appropriate analytical methods (e.g., spectroscopy, chromatography) following standardized test procedures (likely ASTM or similar international standards for chemical permeation of protective clothing).
8. Sample Size for the Training Set
Not applicable. This device is a physical product (surgical glove) whose performance is determined by its material composition and manufacturing process. There is no "training set" in the context of machine learning or AI algorithms for this type of product. The manufacturing process is validated, and the product is tested to meet specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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April 20, 2018
Pt. Medisafe Technologies Deepak Bang Commercial Director J1 Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar, Kecamatan Tanjung Morawa Medan, Indonesia 20362
Re: K173258
Trade/Device Name: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: March 20, 2018 Received: March 23, 2018
Dear Deepak Bang:
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/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.
Geeta K. Pamidimukkala -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) K173258
Device Name
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use With Chemotherapy Drugs
Indications for Use (Describe)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
| Test Chemotherapy Drug and Concentration | Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20.000 ppm) | >240 min |
| Fluorouracil 50.0 mg/ml (50.000 ppm) | >240 min |
| Ifosfamide 50.0 mg/ml (50.000 ppm) | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 min |
Caution: Testing showed an average breakthrough time for Carmustine (3.3 mg/ml): 37.5 minutes and average breakthrough time of ThioTEPA (10.0 mg/ml): 58.3 minutes
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).