(50 days)
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloyes were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The document describes the acceptance criteria and performance of a "Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim." This is a medical device, not an AI/ML device, and thus the acceptance criteria and study data provided are for a physical product, not an algorithm's performance.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and how ground truth for training set was established) are not applicable to this type of device and are not provided in the document.
1. A table of acceptance criteria and the reported device performance:
| Chemotherapy Drug and Concentration | Acceptance Criterion: Minimum Breakthrough Detection Time (minutes) | Reported Device Performance: Minimum Breakthrough Detection Time (minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | 78.4 |
| Cisplatin (1.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Cytarabine(100 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Etoposide (20.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Ifosfamide (50.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Methotrexate (25.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Mitoxantrone (2.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Thiotepa (10.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | 118.8 |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the performance criteria is described as follows:
- Methodology: "These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard practice outlines the procedure for testing the resistance of medical gloves to permeation by chemotherapy drugs.
Details specific to AI/ML device studies (as requested in the prompt but not applicable here):
- Sample size used for the test set and the data provenance: Not applicable. For this physical glove, the "test set" would be the number of gloves tested and the specific conditions per the ASTM standard. This information is not provided beyond the reference to the standard.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical glove's chemical resistance is established by laboratory measurements according to a standard.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance of the chemotherapy drug permeation is established through laboratory testing following the specific protocols of ASTM D6978-05 (Reapproved 2013). This involves precise measurement of breakthrough detection time.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
Wear Safe (Malaysia) Sdn. Bhd. Cho Sow Fong Regulatory Affairs Manager Lot 5068 & 5069, Batu 4 ½, Jalan Meru, 41050 Klang, Selangor, Malaysia
Re: K172420
Trade/Device Name: Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: August 9, 2017 Received: August 10, 2017
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 (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
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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 (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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Indications for Use
510(k) Number (if known)
Device Name
Sterile Powder Free Nitrile Surgical Gloved. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
Indications for Use (Describe)
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloyes were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 78.4 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (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 (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 118.8 |
| Vincristine Sulfate (1.0 mg/ml) | >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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
K172420
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PSC Poblishing Services (301) 443-6740 EF
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K172420
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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).