(164 days)
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient. These gloves are tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.
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The provided document describes the FDA's 510(k) clearance for "Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs" and "Sterile Latex Surgical Powder Free Gloves". The primary "acceptance criteria" and "study" described pertain specifically to the chemotherapy drug permeation resistance of the Nitrile gloves.
Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance (for Nitrile Gloves):
| Chemotherapy Drug | Concentration | Acceptance Criteria (Breakthrough Detection Time - Minutes) | Reported Device Performance (Breakthrough Detection Time - Minutes) |
|---|---|---|---|
| Carmustin (BCNU) | 3.3mg/ml | Not explicitly stated, but practical minimum for safe use. | 8.0 |
| Cisplatin | 1.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Dacarbazine (DTIC) | 10.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Etoposide (Toposar) | 20.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Fluorouracil | 50.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Paclitaxel (Taxol) | 6.0mg/ml | Not explicitly stated, but practical minimum for safe use. | >240 |
| Thiotepa | 10.0mg/ml | Not explicitly stated, but practical minimum for safe use. | 16.2 |
Note: The document states "Please note that the following drugs have extremely low permeation times: Carmustin (BCNU) : 8.0 minutes and Thiotepa : 16.2 minutes." This implies that while the gloves offer some protection, these specific drugs have a limited breakthrough time, which would practically serve as an informal "acceptance criterion" for healthcare professionals to consider when using these gloves with those drugs. The formal acceptance criteria for breakthrough time are typically defined by a standard, but the specific numerical threshold for "acceptable" is not explicitly listed in this document beyond the measured values. The study performed adheres to the ASTM D6978-05 standard, which defines the methodology. It's implied that exceeding the 240-minute mark is generally considered excellent performance for chemotherapy drug resistance.
2. Sample size used for the test set and the data provenance:
- The document states the gloves were "tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs."
- Sample Size: The exact sample size (number of gloves tested per drug) is not specified in this document. The ASTM D6978-05 standard typically dictates the sample size and methodology.
- Data Provenance: This information is not explicitly stated in the provided document (e.g., country of origin, retrospective or prospective). It is likely from the manufacturer's internal testing as part of their 510(k) submission. Given it's a submission to the FDA, the testing was likely prospective for the purpose of demonstrating compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to this type of device and study. The testing for chemotherapy drug permeation is a physical/chemical test performed in a laboratory setting, not an assessment requiring expert consensus on images or clinical outcomes. The "ground truth" is established by the direct measurement of drug permeation according to a standardized method (ASTM D6978-05).
4. Adjudication method for the test set:
- Not applicable. As noted above, this is a laboratory-based permeation test, not a clinical assessment requiring adjudication among multiple readers.
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 surgical glove, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies involving human readers and AI are irrelevant to its evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (gloves), not an algorithm or software.
7. The type of ground truth used:
- The ground truth is established by direct physical/chemical measurement of chemotherapy drug permeation through the glove material using a standardized test method (ASTM D6978-05). This involves quantitative analysis to detect and measure the breakthrough time of the specific drugs.
8. The sample size for the training set:
- Not applicable. This device is a physical product. There is no concept of a "training set" in the context of its evaluation for chemotherapy drug permeation.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 12, 2017
Top Glove SDN BHD Noor Akilah Bt Saidin Deputy General Manager, OA Lot 4968. Jalan Teratai. Batu 6. Off Jalan Meru Klang, 41050 MY
Re: K171279
Trade/Device Name: Sterile Latex Surgical Powder Free Gloves: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Surgeon's Gloves Regulatory Class: Class I Product Code: KGO, LZA, LZC Dated: September 13, 2017 Received: September 13, 2017
Dear Noor Akilah Bt Saidin:
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 (DICE) 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 (DICE) 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.
Michael J. Ryan -S
for Tina Kiang, PhD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.
These gloves are tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustin (BCNU) | 3.3mg/ml | 8.0 |
| Cisplatin | 1.0mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >240 |
| Dacarbazine (DTIC) | 10.0mg/ml | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | >240 |
| Etoposide (Toposar) | 20.0mg/ml | >240 |
| Fluorouracil | 50.0mg/ml | >240 |
| Paclitaxel (Taxol) | 6.0mg/ml | >240 |
| Thiotepa | 10.0mg/ml | 16.2 |
- Please note that the following drugs have extremely low permeation times: Carmustin (BCNU) : 8.0 minutes and Thiotepa : 16.2 minutes
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Sterile Latex Surgical Powder Free Gloves
Indications for Use (Describe)
Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.
| 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) ☒ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
§ 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).