(108 days)
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Is it also tested to be used against Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below;
Carmustine (3.3 mg/ml) 17.2 minutes
Cisplatin (1.0 mg/ml) >240 minutes
Cyclophosphamide (20 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) >240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes
Etoposide (20 mg/ml) > 240 minutes
Fluorouracil (50 mg/ml) > 240 minutes
Methotrexate (25 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxel (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 36.1 minutes
Vincristine Sulfate (1.0 mg/ml) >240 minutes
Do not use with Carmustine. Do not use with Thiotepa.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White)
This document is a 510(k) premarket notification decision letter from the FDA for a Nitrile Powder Free Examination Glove. It is not a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot extract the requested information like "acceptance criteria and the reported device performance," "sample size used for the test set," "number of experts used to establish ground truth," "multi reader multi case (MRMC) comparative effectiveness study," or "sample size for the training set." These concepts are relevant to the evaluation of AI/ML software, not a physical medical device like a glove, which is evaluated against different types of performance standards (e.g., physical properties, barrier protection, biocompatibility, chemical resistance).
The provided text only includes:
- Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
- Regulation Number: 21 CFR 880.6250
- Regulation Name: Patient Examination Glove
- Regulatory Class: Class I
- Product Code: LZA, LZC
- Indications for Use: "Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Is it also tested to be used against Chemotherapy Drugs."
- Chemotherapy Drugs Tested with Breakthrough Times: A table listing specific chemotherapy drugs and their breakthrough times in minutes. This table serves as performance data for the glove's resistance to certain chemicals, but it does not represent "acceptance criteria" in the AI/ML context nor is the study design detailed for how these breakthrough times were determined (e.g., sample size of gloves tested).
- Cautions: "Do not use with Carmustine. Do not use with Thiotepa." (These warnings are based on the breakthrough times being short).
To answer your prompt for an AI/ML device, I would need a different type of document, specifically a study report or a 510(k) submission for an AI/ML product.
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Hartalega Sdn. Bhd. Nurul Kong Ouality Assurance Senior Manager No. 7, Kawasan Perusahaan Suria Bestari Jaya, 45600 My
Re: K180505
Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: May 15, 2018 Received: May 17, 2018
Dear Nurul Kong:
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 comprehensive regulatory information about mediation-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,
Clarence W. Murray
lii III -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 (ifknown) K180505
Device Name
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatial Claim and Tested for Use with Chemotherapy Drugs (White)
Indications for Use (Describe)
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Is it also tested to be used against Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below;
| Carmustine (3.3 mg/ml) | 17.2 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (20 mg/ml) | > 240 minutes |
| Dacarbazine (10.0 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (20 mg/ml) | > 240 minutes |
| Fluorouracil (50 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 36.1 minutes |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
Do not use with Carmustine. Do not use with Thiotepa.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
XOver-The-Counter Use(21CFR801 SubpartC)
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§ 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.