(151 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs
The provided text is a 510(k) premarket notification for patient examination gloves, specifically focusing on their resistance to chemotherapy drugs. The study described is a chemical permeation test, not a study involving AI, human readers, or medical imaging. Therefore, many of the requested criteria (like ground truth establishment with experts, MRMC studies, or training set details) are not applicable to this type of device and study.
However, I can extract the acceptance criteria and the device's performance based on the provided tables.
Acceptance Criteria and Device Performance for Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs (K170397)
The acceptance criterion for these gloves regarding chemotherapy drug permeation is established by the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The "Minimum Breakthrough Detection Time" listed in the table represents the device's performance against each specified drug. Implicitly, for the device to be considered acceptable, the breakthrough time must meet or exceed a certain, unstated, threshold relative to the expected duration of risk or exposure. For most drugs, a breakthrough time of ">240 minutes" indicates high resistance. However, the manufacturer notes that Carmustine (BCNU) and Thiotepa show significantly lower breakthrough times, indicating they are aware of and disclosing these specific limitations against their acceptance criteria.
Table of Acceptance Criteria and Reported Device Performance (Blue Colored Glove)
| Chemotherapy Drug and Concentration | Acceptance Criteria (Based on ASTM D6978-05 standard, generally aiming for high resistance) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | Defined by ASTM D6978-05, no specific numerical threshold provided here for individual drugs beyond the general standard. | 10.2 |
| Cisplatin (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cytarabine (100 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Etoposide (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Fluorouracil (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Ifosfamide (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Methotrexate (25.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitomycin C (0.5 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitoxantrone (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Thiotepa (10.0 mg/ml) | Defined by ASTM D6978-05 | 30.4 |
| Vincristine Sulfate (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
Acceptance Criteria and Device Performance for Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs (K170397)
The acceptance criterion for these gloves is identical, based on ASTM D6978-05 (Reapproved 2013).
Table of Acceptance Criteria and Reported Device Performance (White Colored Glove)
| Chemotherapy Drug and Concentration | Acceptance Criteria (Based on ASTM D6978-05 standard, generally aiming for high resistance) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | Defined by ASTM D6978-05 | 10.1 |
| Cisplatin (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cytarabine (100 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Etoposide (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Fluorouracil (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Ifosfamide (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Methotrexate (25.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitomycin C (0.5 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitoxantrone (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Thiotepa (10.0 mg/ml) | Defined by ASTM D6978-05 | 30.4 |
| Vincristine Sulfate (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
Since this is a report for medical gloves and not an AI/imaging device, the following points are not applicable (N/A) based on the provided text:
- Sample size used for the test set and the data provenance: The document does not specify the number of gloves tested for each drug, only the minimum breakthrough detection time. Data provenance refers to the origin of the materials or testing, which would presumably be the manufacturer's testing facilities (Kossan International Sdn. Bhd. in Malaysia). This is a measurement of physical properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for chemical permeation is established by direct measurement using specified laboratory methods (ASTM D6978-05). It does not require human expert consensus or interpretation in the way AI or imaging studies do.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. Adjudication is for human interpretation of data, not physical property testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: N/A. This is a framework for comparing human reader performance, typically with and without AI assistance in medical imaging.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. The device is a physical glove, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is the measured breakthrough time as determined by the ASTM D6978-05 standard, which describes the specific laboratory methodology to assess permeation.
- The sample size for the training set: N/A. There is no concept of a "training set" for physical product testing via a standardized method like ASTM D6978-05.
- How the ground truth for the training set was established: N/A.
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July 10, 2017
Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Kossan International Sdn. Bhd. Cho Fong RA Manager Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 3/34, Jalan Kapar. Klang, 42100 MY
Re: K170397
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: June 8, 2017 Received: June 12, 2017
Dear Cho 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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good 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.
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 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 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,
Mark S. Fellman -S
for
Lori A. Wiggins, MPT, CLT 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) K170397
Device Name
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotheray Drugs
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with cherapy drugs 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) | 10.2 |
| 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) | 30.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine (BCNU) and Thiotepa has extremely low permeation times of 10.2 minutes and 30.4 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.
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Indications for Use
510(k) Number (if known) K170397
Device Name
Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotheray Drugs
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs 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) | 10.1 |
| 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) | 30.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine (BCNU) and Thiotepa has extremely low permeation times of 10.1 minutes and 30.4 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.
§ 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.