Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentaryl 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.

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.

The following drugs and concentrations have been tested the minimum breakthrough result of >240 minutes: Arsenic Trioxide 1.0 Azacitidine (Vidaza) 25.0 Bendamustine HCl 5.0 Bleomycin Sulfate 15.0 Busulfan 6.0 Carboplatin 10.0 Carfilzomib 2.0 Cetuximab 2.0 Chloroquine 50.0 Cisplatin 1.0 Cladribine 1.0 Cyclophosphamide (Cytoxan) 20.0 Cyclosporin A 100.0 Cytarabine 100.0 Cytovene (Ganciclovir) 10.0 Dacarbazine 10.0 Daunorubicin 5.0 Decitibine 5.0 Docetaxel 10.0 Doxorubicin Hydrochloride 2.0 Epirubicin (Ellence) 2.0 Etoposide (Toposar) 20.0 Fludarabine 25.0 Fluorouracil 50.0 Fulvestrant 50.0 Gemcitabine (Gemzar) 38.0 Idarubicin 1.0 Ifosfamide 50.0 Irinotecan 20.0 Mechlorethamine HCl 1.0 Melphalan 5.0 Mesna 50.0 Methotrexate 25.0 Mitomycin C 0.5 Mitoxantrone 2.0 Oxaliplatin 2.0 Paclitaxel 6.0 Paraplatin 10.0 Pemetrexed 25.0 Pertuzumab 30.0 Propofol 10.0 Raltitrexed 0.5 Retrovir 10.0 Rituximab 10.0 Temsirolimus 25.0 Topotecan HCl 1.0 Trastuzumab 21.0 Triclosan 2.0 Trisenox (Arsenic Trioxide) 1.0 Velcade (Bortezomib) 1.0 Vinblastine 1.0 Vincristine Sulfate 1.0 Vinorelbine 10.0 Zoledronic Acid 0.8

The following drugs have permeation times lower than 240 minutes: Carnustine: 55.1 minutes and Thiotepa: 199.2 minutes.

Fentaryl Permeation Resistance Claim - 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 Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

Device Description

AI/ML Overview

This document is a 510(k) clearance letter for Blue Non Sterile Powder Free Nitrile Examination Gloves. It details the device's intended use and claims about its resistance to chemotherapy drugs, gastric acid, and fentanyl permeation. It does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/machine learning device.

The questions in the prompt are specific to the performance evaluation of an AI/machine learning-based medical device. This document describes the device performance claims for a physical medical device (gloves) based on physical permeation testing against various chemical agents, not an AI algorithm.

Therefore, I cannot provide answers to the requested information based on the provided text. The document does not describe:

A table of acceptance criteria and reported device performance: While drug permeation times are listed, these are performance metrics for a physical glove, not an AI device. There are no "acceptance criteria" in the AI sense (e.g., target precision, recall, AUC).
Sample size for test set and data provenance: Not applicable to a physical glove's chemical resistance testing.
Number of experts for ground truth and qualifications: Not applicable; ground truth for chemical resistance is determined by laboratory measurements, not expert consensus.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for human reader performance with/without AI assistance.
Standalone (algorithm only) performance: Not applicable; there is no algorithm.
Type of ground truth used: For these gloves, the "ground truth" is laboratory measurement of chemical permeation according to ASTM D6978-05.
Sample size for the training set: Not applicable; there's no training set for an AI algorithm.
How ground truth for the training set was established: Not applicable.

The document describes the testing methodology for the gloves' chemical resistance, which is analogous to how device performance is evaluated, but it's for a physical product, not an AI system. Specifically:

Acceptance Criteria/Performance: The device "acceptably" resists permeation by various chemotherapy drugs, gastric acid, and fentanyl.
- For most listed chemotherapy drugs, the minimum breakthrough result was ">240 minutes" when tested according to ASTM D6978-05.
- For BCNU (Carmustine) and Thiotepa, permeation times were lower (55.1 minutes and 199.2 minutes, respectively).
- For Fentanyl Citrate Injection and Gastric Acid, no breakthrough was detected up to 240 minutes.
Study Proving Acceptance: The device was tested for use with chemotherapy drugs, gastric acid, and fentanyl permeation resistance claims using ASTM D6978-05. This standard dictates the testing methodology for assessing the resistance of medical gloves to permeation by chemotherapy drugs. The results obtained from this standard testing are what "prove" the device meets its claims.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

April 11, 2022

Central Medicare Sdn Bhd Fatin Nor Fauzi Product Process Engineer PT 2609-2620, Batu 8, Jalan Changkat Jong Teluk Intan, Perak 36000 Malaysia

Re: K213437

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, QDO, Dated: April 4, 2022 Received: April 4, 2022

Dear Fatin Nor Fauzi:

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.

Clarence W. Murray, III, PhD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K213437

Device Name

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims

Indications for Use (Describe)

FORM FDA 3881 (6/20)

Mitomycin C 0.5 Mitoxantrone 2.0

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Oxaliplatin 2.0 Paclitaxel 6.0 Paraplatin 10.0 Pemetrexed 25.0 Pertuzumab 30.0 Propofol 10.0 Raltitrexed 0.5 Retrovir 10.0 Rituximab 10.0 Temsirolimus 25.0 Topotecan HCl 1.0 Trastuzumab 21.0 Triclosan 2.0 Trisenox (Arsenic Trioxide) 1.0 Velcade (Bortezomib) 1.0 Vinblastine 1.0 Vincristine Sulfate 1.0 Vinorelbine 10.0 Zoledronic Acid 0.8

The following drugs have permeation times lower than 240 minutes: Carnustine: 55.1 minutes and Thiotepa: 199.2 minutes.

Fentaryl Permeation Resistance Claim - 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 Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

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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Regulation Number and Section

§ 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.