(221 days)
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with chloroquine, cyclosporin A, retrovir, gastric acid and fentanyl citrate in accordance with ASTM D6978-05(2019).
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The provided text describes information about Black Non Sterile Powder Free Nitrile Examination Gloves, tested for use with various chemotherapy and non-chemotherapy drugs. It is a 510(k) premarket notification for a Class I device.
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 implicitly defined by the testing against ASTM D6978-05(2019) for breakthrough detection time for various drugs. The performance is reported as the "Breakthrough Detection Time in Minutes." The general acceptance is that gloves should resist permeation by these drugs for a significant duration, ideally greater than 240 minutes, which is a common benchmark for such tests.
| Acceptance Criteria (Implicit) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|
| Resist permeation by Bleomycin Sulfate for a significant duration | > 240 mins |
| Resist permeation by Busulfan for a significant duration | > 240 mins |
| Resist permeation by Carboplatin for a significant duration | > 240 mins |
| Resist permeation by Carmustine (BCNU) for a significant duration | 13.2 mins |
| Resist permeation by Cisplatin for a significant duration | > 240 mins |
| Resist permeation by Cyclophosphamide (Cytoxan) for a significant duration | > 240 mins |
| Resist permeation by Cytarabine (Cytosine) for a significant duration | > 240 mins |
| Resist permeation by Dacarbazine for a significant duration | > 240 mins |
| Resist permeation by Daunorubicin HCl for a significant duration | > 240 mins |
| Resist permeation by Docetaxel for a significant duration | > 240 mins |
| Resist permeation by Doxorubicin HCl for a significant duration | > 240 mins |
| Resist permeation by Epirubicin HCl (Ellence) for a significant duration | > 240 mins |
| Resist permeation by Etoposide (Toposar) for a significant duration | > 240 mins |
| Resist permeation by Fludarabine for a significant duration | > 240 mins |
| Resist permeation by Fluorouracil for a significant duration | > 240 mins |
| Resist permeation by Gemcitabine (Gemzar) for a significant duration | > 240 mins |
| Resist permeation by Idarubicin HCl for a significant duration | > 240 mins |
| Resist permeation by Ifosfamide for a significant duration | > 240 mins |
| Resist permeation by Irinotecan for a significant duration | > 240 mins |
| Resist permeation by Mechlorethamine HCl for a significant duration | > 240 mins |
| Resist permeation by Melphalan for a significant duration | > 240 mins |
| Resist permeation by Methotrexate for a significant duration | > 240 mins |
| Resist permeation by Mitomycin C for a significant duration | > 240 mins |
| Resist permeation by Mitoxantrone HCl for a significant duration | > 240 mins |
| Resist permeation by Oxaliplatin for a significant duration | > 240 mins |
| Resist permeation by Paclitaxel for a significant duration | > 240 mins |
| Resist permeation by Paraplatin for a significant duration | > 240 mins |
| Resist permeation by Rituximab for a significant duration | > 240 mins |
| Resist permeation by Thiotepa for a significant duration | 34.7 mins |
| Resist permeation by Topotecan HCl for a significant duration | > 240 mins |
| Resist permeation by Trisenox (Arsenic Trioxide) for a significant duration | > 240 mins |
| Resist permeation by Velcade (Bortezomib) for a significant duration | > 240 mins |
| Resist permeation by Vincristine Sulfate for a significant duration | > 240 mins |
| Resist permeation by Chloroquine for a significant duration | > 240 mins |
| Resist permeation by Cyclosporin A for a significant duration | > 240 mins |
| Resist permeation by Retrovir for a significant duration | > 240 mins |
| Resist permeation by Fentanyl Citrate Injection (100mcg/2mL) for a significant duration | No breakthrough detected up to 240 minutes |
| Resist permeation by Gastric Acid for a significant duration | No breakthrough detected up to 240 minutes |
Important Note: The document explicitly states a caution and warning for Carmustine and Thiotepa due to significantly lower breakthrough times (13.2 minutes and 34.7 minutes respectively), indicating these are not acceptable for extended use with these specific drugs.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size (e.g., number of gloves tested for each drug). It mentions "average breakthrough detection time," which implies multiple samples were tested. The data provenance is testing "in accordance with ASTM D6978-05(2019)," which is a standardized testing method. The document originated from Central Medicare Sdn. Bhd. in Malaysia, suggesting the testing was likely conducted in Malaysia or under their supervision. The information is presented in a regulatory submission to the FDA, which generally implies the data is gathered for the purpose of demonstrating device safety and effectiveness. It is a report of testing, which by nature is prospective data collection for evaluating the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" here is objective measurement of breakthrough time, determined by laboratory instruments and procedures as defined by the ASTM D6978-05(2019) standard, not by expert interpretation or consensus.
4. Adjudication method for the test set
This information is not applicable. As the "ground truth" is an objective measurement based on a standardized test method (ASTM D6978-05(2019)), there is no need for expert adjudication.
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
This information is not applicable. This document describes the performance of a physical medical device (gloves) against chemical permeation, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithmic or software device. The performance data is for the physical glove itself.
7. The type of ground truth used
The ground truth used is objective laboratory measurement based on established chemical permeation testing for protective clothing materials, specifically "breakthrough detection time" according to ASTM D6978-05(2019).
8. The sample size for the training set
This information is not applicable. This is not a machine learning or AI-driven device that requires training data in the conventional sense. The device's performance is intrinsic to its material and manufacturing.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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July 24, 2023
Central Medicare Sdn. Bhd. Chua Kah Ying Product Executive PT 2609-2620, Batu 8, Jalan Changkat Jong Teluk Intan, Perak 36000 Malaysia
Re: K223752
Trade/Device Name: Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: June 22, 2023 Received: June 22, 2023
Dear Chua Kah Ying:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223752
Device Name
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
Indications for Use (Describe)
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with chloroquine, cyclosporin A, retrovir, gastric acid and fentanyl citrate in accordance with ASTM D6978-05(2019).
Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows:
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Bleomycin Sulfate | 15.0 mg/ml | > 240 mins |
| Busulfan | 6.0 mg/ml | > 240 mins |
| Carboplatin | 10.0 mg/ml | > 240 mins |
| Carmustine (BCNU) | 3.3 mg/ml | 13.2 mins |
| Cisplatin | 1.0 mg/ml | > 240 mins |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 mins |
| Cytarabine (Cytosine) | 100.0 mg/ml | > 240 mins |
| Dacarbazine | 10.0 mg/ml | > 240 mins |
| Daunorubicin HCl | 5.0 mg/ml | > 240 mins |
| Docetaxel | 10.0 mg/ml | > 240 mins |
| Doxorubicin HCl | 2.0 mg/ml | > 240 mins |
| Epirubicin HCl (Ellence) | 2.0 mg/ml | > 240 mins |
| Etoposide (Toposar) | 20.0 mg/ml | > 240 mins |
| Fludarabine | 25.0 mg/ml | > 240 mins |
| Fluorouracil | 50.0 mg/ml | > 240 mins |
| Gemcitabine (Gemzar) | 38.0 mg/ml | > 240 mins |
| Idarubicin HCl | 1.0 mg/ml | > 240 mins |
| Ifosfamide | 50.0 mg/ml | > 240 mins |
| Irinotecan | 20.0 mg/ml | > 240 mins |
| Mechlorethamine HCl | 1.0 mg/ml | > 240 mins |
| Melphalan | 5.0 mg/ml | > 240 mins |
| Methotrexate | 25.0 mg/ml | > 240 mins |
| Mitomycin C | 0.5 mg/ml | > 240 mins |
| Mitoxantrone HCl | 2.0 mg/ml | > 240 mins |
| Oxaliplatin | 5.0 mg/ml | > 240 mins |
| Paclitaxel | 6.0 mg/ml | > 240 mins |
| Paraplatin | 10.0 mg/ml | > 240 mins |
| Rituximab | 10.0 mg/ml | > 240 mins |
| Thiotepa | 10.0 mg/ml | 34.7 mins |
| Topotecan HCl | 1.0 mg/ml | > 240 mins |
| Trisenox (Arsenic Trioxide) | 1.0 mg/ml | > 240 mins |
| Velcade (Bortezomib) | 1.0 mg/ml | > 240 mins |
| Vincristine Sulfate | 1.0 mg/ml | > 240 mins |
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| Tested non-chemotherapy drugs and average breakthrough detection time (minutes) are as follows: | ||
|---|---|---|
| Non-Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
| Chloroquine | 50.0 mg/ml | > 240 mins |
| Cyclosporin A | 100.0 mg/ml | > 240 mins |
| Retrovir | 10.0 mg/ml | > 240 mins |
Fentanyl Permeation - Under the testing conditions of ASTM D6978-05(2019), Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Gastric Acid Permeation - Under the testing conditions of ASTM D6978-05(2019), was found to have no breakthrough detected up to 240 minutes.
CAUTION: Testing showed an average breakthrough time of 13.2 minutes with Carmustine and 34.7 minutes with Thiotepa.
WARNING: Do not use with Carmustine and Thiotepa.
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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§ 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.