(85 days)
A Nitrile powder free examination glove is a disposable device intended purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with 46 Chemotherapy drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate.
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
This document is an FDA 510(k) premarket notification letter for "Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)". This is a Class I medical device (non-powdered patient examination glove).
The document does not describe an AI/ML-driven medical device, nor does it contain information about clinical study results, expert adjudication, or ground truth establishment relevant to AI/ML device performance. It is a regulatory clearance letter for a physical product (gloves) and lists testing results for breakthrough times against various chemicals for the purpose of demonstrating the device's protective capabilities.
Therefore, the requested information cannot be extracted from the provided text. The questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not applicable to the content of this document.
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September 11, 2024
KSG Medicare Sdn. Bhd. % Wava Truscott Consultant/Contact Truscott MedSci Associates, LLC. 180 Burkemeade Ct. Roswell, Georgia 30075
Re: K241745
Trade/Device Name: Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) 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: June 12, 2024 Received: June 18, 2024
Dear Wava Truscott:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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 Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control 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) K241745
Device Name
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentary Litrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine in Fentanyl citrate (Blue)
Indications for Use (Describe)
A Nitrile powder free examination glove is a disposable device intended purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with 46 Chemotherapy drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate.
| CHEMOTHERAPY DRUG | No Breakthrough up to |
|---|---|
| Azacytidine (Vidaza), 25 mg/ml | >240 min. |
| Bendamustine HCI, 5 mg/ml | >240 min. |
| Bleomycin Sulfate, 15 mg/ml | >240 min. |
| Bortezomib (Velcade), 1 mg/ml | >240 min. |
| Busulfan, 6 mg/ml | >240 min. |
| Carboplatin, 10 mg/ml | >240 min. |
| Carfilzomib, 2 mg/ml | >240 min. |
| Carmustine, 3.3 mg/ml | 13.6 min. |
| Cetuximab (Erbitux), 2 mg/ml | >240 min. |
| Cisplatin, 1 mg/ml | >240 min. |
| Cladribine, 1 mg/ml | >240 min. |
| Cyclophosphamide, 20 mg/ml | >240 min. |
| Cyclosporin A, 100 mg/ml | >240 min. |
| Cytarabine HCI (Cytosine) | >240 min. |
| Cytovene (Ganciclovir) 10 mg/ml | >240 min. |
| Dacarbazine (DTIC), 10 mg/ml | >240 min. |
| Daunorubicin HCI, 5 mg/ml | >240 min. |
| Decitabine, 5 mg/ml | >240 min. |
| Docetaxel, 10 mg/ml | >240 min. |
| Doxorubicin HCI, 2 mg/ml | >240 min. |
| Epirubicin HCI, 2 mg/ml | >240 min. |
| Etoposide, 20 mg/ml | >240 min. |
| Fludarabine Phosphate, 25 mg/ml | >240 min. |
| 5-Fluorouracil, 50 mg/ml | >240 min. |
| Gemcitabine HCI, 38 mg/ml | >240 min. |
| Idarubicin HCI, 1 mg/ml | >240 min. |
| Ifosfamide (IFEX), 50 mg/ml | >240 min. |
| Irinotecan HCI, 20 mg/ml | >240 min. |
| Mechlorethamine HCI, 1 mg/ml | >240 min. |
| Melphalan HCI, 5 mg/ml | >240 min. |
| Methotrexate, 25 mg/ml | >240 min. |
| Mitomycin C, 0.5 mg/ml | >240 min. |
| Mitoxantrone HCI, 2 mg/ml | >240 min. |
| Oxaliplatin, 5 mg/ml | >240 min. |
| Paclitaxel (Taxol),6 mg/ml | >240 min. |
| Pemetrexed, 25 mg/ml | >240 min. |
| Raltitrexed, 0.5 mg/ml | >240 min. |
| Retrovir (Zidovudine), 10mg/ml | >240 min. |
| Rituximab, 10 mg/ml | >240 min. |
| ThioTEPA, 10 mg/ml | 24.3 min. |
| Topotecan HCI, 1 mg/ml | >240 min. |
| Trisenox (Arsenic Trioxide), 1 mg/ml | >240 min. |
| Vinblastine Sulfate, 1 mg/ml | >240 min. |
| Vincristine Sulfate (Oncovin), 1 mg/ml | >240 min. |
| Vinorelbine, 10 mg/ml | >240 min. |
| Zoledronic Acid, 0.8 mg/ml | >240 min. |
Caution: Carmustine and ThioTepa have extremely low minimal breakthrough times of 13.6 minutes and 24.3 minutes respectively. Warning: Do not use with Carmustine or ThioTepa
| Opioid Drug and Concentration Tested | No Breakthrough up to: |
|---|---|
| Fentanyl citrate, (injectable) 100 mg/2ml | >240 minutes |
| Gastric Acid (simulated), 0.2% NaCl in 0.7% HCL | >240 minutes |
| Fentanyl in Gastric Acid 50/50 mix | >240 minutes |
| Tranquilizer Xylazine Drug and Concentration Tested | No Breakthrough up to: |
| Xylazine HCL, 100 mg/ml | >240 minutes |
| Xylazine HCL, 100mg/ml in Fentanyl citrate | >240 minutes |
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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.