(112 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims 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 gastric acid and fentanyl citrate in accordance with ASTM D6978-05.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Fentanyl Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Gastric Acid Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This document is a 510(k) premarket notification from the FDA for "Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims."
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are defined by the performance standards outlined for the permeation resistance of the gloves to various drugs. The device performance is reported as the "Breakthrough Detection Time in Minutes." The general implicit acceptance criterion for most drugs appears to be a breakthrough time of "> 240 minutes," indicating that the glove provides protection for at least 4 hours.
Chemotherapy Drug Concentration Acceptance Criteria (Implicit) Reported Device Performance (Breakthrough Detection Time in Minutes) Arsenic Trioxide 1.0 mg/ml > 240 minutes > 240 minutes Azacitidine (Vidaza) 25.0 mg/ml > 240 minutes > 240 minutes Bendamustine HCl 5.0 mg/ml > 240 minutes > 240 minutes Bleomycin Sulfate 15.0 mg/ml > 240 minutes > 240 minutes Busulfan 6.0 mg/ml > 240 minutes > 240 minutes Carboplatin 10.0 mg/ml > 240 minutes > 240 minutes Carmustine (BCNU) 3.3 mg/ml > 240 minutes (Implied) 77.6 minutes Carfilzomib 2.0 mg/ml > 240 minutes > 240 minutes Cisplatin 1.0 mg/ml > 240 minutes > 240 minutes Cladribine 1.0 mg/ml > 240 minutes > 240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 minutes > 240 minutes Cytarabine 100.0 mg/ml > 240 minutes > 240 minutes Dacarbazine 10.0 mg/ml > 240 minutes > 240 minutes Daunorubicin 5.0 mg/ml > 240 minutes > 240 minutes Decitibine 5.0 mg/ml > 240 minutes > 240 minutes Docetaxel 10.0 mg/ml > 240 minutes > 240 minutes Doxorubicin Hydrochloride 2.0 mg/ml > 240 minutes > 240 minutes Epirubicin (Ellence) 2.0 mg/ml > 240 minutes > 240 minutes Etoposide (Toposar) 20.0 mg/ml > 240 minutes > 240 minutes Fludarabine 25.0 mg/ml > 240 minutes > 240 minutes Fluorouracil 50.0 mg/ml > 240 minutes > 240 minutes Gemcitabine (Gemzar) 38.0 mg/ml > 240 minutes > 240 minutes Idarubicin 1.0 mg/ml > 240 minutes > 240 minutes Ifosfamide 50.0 mg/ml > 240 minutes > 240 minutes Irinotecan 20.0 mg/ml > 240 minutes > 240 minutes Mechlorethamine HCl 1.0 mg/ml > 240 minutes > 240 minutes Melphalan 5.0 mg/ml > 240 minutes > 240 minutes Mesna 50.0 mg/ml > 240 minutes > 240 minutes Methotrexate 25.0 mg/ml > 240 minutes > 240 minutes Mitomycin C 0.5 mg/ml > 240 minutes > 240 minutes Mitoxantrone 2.0 mg/ml > 240 minutes > 240 minutes Oxaliplatin 2.0 mg/ml > 240 minutes > 240 minutes Paclitaxel 6.0 mg/ml > 240 minutes > 240 minutes Paraplatin 10.0 mg/ml > 240 minutes > 240 minutes Pemetrexed 25.0 mg/ml > 240 minutes > 240 minutes Pertuzumab 30.0 mg/ml > 240 minutes > 240 minutes Raltitrexed 0.5 mg/ml > 240 minutes > 240 minutes Retrovir 10.0 mg/ml > 240 minutes > 240 minutes Temsirolimus 25.0 mg/ml > 240 minutes > 240 minutes Thiotepa 10.0 mg/ml > 240 minutes > 240 minutes Topotecan HCI 1.0 mg/ml > 240 minutes > 240 minutes Trisenox (Arsenic Trioxide) 1.0 mg/ml > 240 minutes > 240 minutes Velcade (Bortezomib) 1.0 mg/ml > 240 minutes > 240 minutes Vinblastine 1.0 mg/ml > 240 minutes > 240 minutes Vincristine Sulfate 1.0 mg/ml > 240 minutes > 240 minutes Vinorelbine 10.0 mg/ml > 240 minutes > 240 minutes Non-Chemotherapy Drug Concentration Acceptance Criteria (Implicit) Reported Device Performance (Breakthrough Detection Time in Minutes) Cetuximab 2.0 mg/ml > 240 minutes > 240 minutes Chloroquine 50.0 mg/ml > 240 minutes > 240 minutes Cyclosporin A 100.0 mg/ml > 240 minutes > 240 minutes Cytovene (Ganciclovir) 10.0 mg/ml > 240 minutes > 240 minutes Fulvestrant 50.0 mg/ml > 240 minutes > 240 minutes Propofol 10.0 mg/ml > 240 minutes > 240 minutes Rituximab 10.0 mg/ml > 240 minutes > 240 minutes Trastuzumab 21.0 mg/ml > 240 minutes > 240 minutes Triclosan 2.0 mg/ml > 240 minutes > 240 minutes Zoledronic Acid 0.8 mg/ml > 240 minutes > 240 minutes Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes No breakthrough detected up to 240 minutes Gastric Acid Not specified No breakthrough up to 240 minutes No breakthrough detected up to 240 minutes Note: For Carmustine, the device did not meet the implied acceptance criteria of >240 minutes, and this is highlighted with a caution and warning in the document ("CAUTION: Testing showed an average breakthrough time of 77.6 minutes with Carmustine. WARNING: Do not use with Carmustine.").
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size (e.g., number of gloves tested) for each drug. It states "Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05." ASTM D6978-05 is a standard test method, which would specify the number of specimens to be tested, but this detail is not provided in the FDA letter.
The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a medical device (examination gloves) that is physically tested for permeation resistance. The "ground truth" is established through laboratory testing according to a recognized standard (ASTM D6978-05), not through expert consensus or interpretation of medical images. Therefore, the concept of "experts" in the context of clinical interpretation/diagnosis is not applicable here. The experts would be the laboratory personnel performing the tests according to the ASTM standard. Their qualifications are not specified but would typically involve training in chemical permeation testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 typically refer to reaching a consensus among multiple human readers for diagnostic tasks. This is not applicable to the physical permeation testing of gloves. The results are obtained directly from chemical analysis and measurement equipment according to a standardized protocol, so no human adjudication in that sense is necessary.
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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
No MRMC comparative effectiveness study was conducted or is relevant for this type of device (medical examination gloves). This document pertains to the physical performance of gloves, not diagnostic AI software that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI-enabled device or algorithm. It is a physical product (gloves). Therefore, no "standalone" algorithm performance study was done.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth is established through objective laboratory testing against a recognized standard (ASTM D6978-05), which measures the breakthrough detection time of specific chemicals through the glove material. It is not based on expert consensus, pathology, or outcomes data.
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The sample size for the training set
This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The gloves are physically manufactured and then tested.
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How the ground truth for the training set was established
As explained above, there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2023
Central Medicare Sdn. Bhd. Chua Kah Ying Product Executive PT 2609-2620, Batu 8, Jalan Changkat Jong Teluk Intan, Perak 36000 Malaysia
Re: K230875
Trade/Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: May 23, 2023 Received: May 25, 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 mediation-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.
Allan Guan -S
For Bifeng Oian, 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) K230875
Device Name
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Castric Acid and Fentanyl Permeation Resistance Claims
Indications for Use (Describe)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims 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 gastric acid and fentanyl citrate in accordance with ASTM D6978-05.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows:
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Arsenic Trioxide | 1.0 mg/ml | > 240 minutes |
| Azacitidine (Vidaza) | 25.0 mg/ml | > 240 minutes |
| Bendamustine HCl | 5.0 mg/ml | > 240 minutes |
| Bleomycin Sulfate | 15.0 mg/ml | > 240 minutes |
| Busulfan | 6.0 mg/ml | > 240 minutes |
| Carboplatin | 10.0 mg/ml | > 240 minutes |
| Carmustine (BCNU) | 3.3 mg/ml | 77.6 minutes |
| Carfilzomib | 2.0 mg/ml | > 240 minutes |
| Cisplatin | 1.0 mg/ml | > 240 minutes |
| Cladribine | 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 minutes |
| Cytarabine | 100.0 mg/ml | > 240 minutes |
| Dacarbazine | 10.0 mg/ml | > 240 minutes |
| Daunorubicin | 5.0 mg/ml | > 240 minutes |
| Decitibine | 5.0 mg/ml | > 240 minutes |
| Docetaxel | 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 minutes |
| Epirubicin (Ellence) | 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | > 240 minutes |
| Fludarabine | 25.0 mg/ml | > 240 minutes |
| Fluorouracil | 50.0 mg/ml | > 240 minutes |
| Gemcitabine (Gemzar) | 38.0 mg/ml | > 240 minutes |
| Idarubicin | 1.0 mg/ml | > 240 minutes |
| Ifosfamide | 50.0 mg/ml | > 240 minutes |
| Irinotecan | 20.0 mg/ml | > 240 minutes |
| Mechlorethamine HCl | 1.0 mg/ml | > 240 minutes |
| Melphalan | 5.0 mg/ml | > 240 minutes |
| Mesna | 50.0 mg/ml | > 240 minutes |
| Methotrexate | 25.0 mg/ml | > 240 minutes |
| Mitomycin C | 0.5 mg/ml | > 240 minutes |
| Mitoxantrone | 2.0 mg/ml | > 240 minutes |
| Oxaliplatin | 2.0 mg/ml | > 240 minutes |
| Paclitaxel | 6.0 mg/ml | > 240 minutes |
FORM FDA 3881 (6/20)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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| Paraplatin | 10.0 mg/ml | > 240 minutes |
|---|---|---|
| Pemetrexed | 25.0 mg/ml | > 240 minutes |
| Pertuzumab | 30.0 mg/ml | > 240 minutes |
| Raltitrexed | 0.5 mg/ml | > 240 minutes |
| Retrovir | 10.0 mg/ml | > 240 minutes |
| Temsirolimus | 25.0 mg/ml | > 240 minutes |
| Thiotepa | 10.0 mg/ml | > 240 minutes |
| Topotecan HCI | 1.0 mg/ml | > 240 minutes |
| Trisenox (Arsenic Trioxide) | 1.0 mg/ml | > 240 minutes |
| Velcade (Bortezomib) | 1.0 mg/ml | > 240 minutes |
| Vinblastine | 1.0 mg/ml | > 240 minutes |
| Vincristine Sulfate | 1.0 mg/ml | > 240 minutes |
| Vinorelbine | 10.0 mg/ml | > 240 minutes |
Tested non-chemotherapy drugs and average breakthrough detection time (minutes) are as follows:
| Non-Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Cetuximab | 2.0 mg/ml | > 240 minutes |
| Chloroquine | 50.0 mg/ml | > 240 minutes |
| Cyclosporin A | 100.0 mg/ml | > 240 minutes |
| Cytovene (Ganciclovir) | 10.0 mg/ml | > 240 minutes |
| Fulvestrant | 50.0 mg/ml | > 240 minutes |
| Propofol | 10.0 mg/ml | > 240 minutes |
| Rituximab | 10.0 mg/ml | > 240 minutes |
| Trastuzumab | 21.0 mg/ml | > 240 minutes |
| Triclosan | 2.0 mg/ml | > 240 minutes |
| Zoledronic Acid | 0.8 mg/ml | > 240 minutes |
Fentanyl Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Gastric Acid Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
CAUTION: Testing showed an average breakthrough time of 77.6 minutes with Carmustine.
WARNING: Do not use with Carmustine.
| 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) |
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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.