(203 days)
Not Found
Not Found
No
The device is a physical examination glove and the summary describes testing for chemical resistance, not AI/ML functionality.
No.
The device description states it is an examination glove intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic action.
No
Explanation: The device is a glove intended to prevent contamination between patient and examiner and has been tested for chemical resistance. It does not perform any diagnostic function.
No
The device is described as physical gloves, which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- Device Function: The description clearly states that this device is a glove worn on the examiner's hand to prevent contamination. It acts as a barrier.
- Lack of Diagnostic Testing: The device does not perform any tests on biological samples to provide diagnostic information. The testing mentioned (ASTM D6978-05) is related to the glove's barrier properties against certain substances, not a diagnostic test on a patient sample.
Therefore, based on the provided information, this device is a medical device used for protection and barrier purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with 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 gastric acid and fentanyl citrate in accordance with ASTM D6978-05.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, ODO, OPJ
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"examiner" - implied medical professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05. Key results are provided in a table listing chemotherapy drugs, concentration, and breakthrough detection time in minutes. For most drugs, the breakthrough detection time was > 240 minutes. Carmustine showed a breakthrough time of 55.1 minutes, and Thiotepa showed 98.7 minutes. Fentanyl Citrate Injection (100mcg/2mL) and Gastric Acid had no breakthrough detected up to 240 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Breakthrough Detection Time (minutes)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows 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.
October 2, 2023
Central Medicare Sdn. Bhd. Chua Kah Ying Product Executive PT 2609-2620, Batu 8, Jalan Changkat Jong Teluk Intan, Perak 36000 Malaysia
Re: K230681
Trade/Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with 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: August 16, 2023 Received: August 21, 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 (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.
1
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 (OS) 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 820.70) 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 (QS) 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.
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 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 bv email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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) K230681
Device Name
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
Indications for Use (Describe)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with 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 gastric acid and fentanyl citrate in accordance with ASTM D6978-05.
Tested chemotherapy drugs and 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 | 15.0mg/ml | > 240 minutes |
| Busulfan | 6.0 mg/ml | > 240 minutes |
| Carboplatin | 10.0 mg/ml | > 240 minutes |
| Carmustine (BCNU) | 3.3 mg/ml | 55.1 minutes |
| Carfilzomib | 2.0 mg/ml | > 240 minutes |
| Cetuximab | 2.0 mg/ml | > 240 minutes |
| Chloroquine | 50.0 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 |
| Cyclosporin A | 100.0 mg/ml | > 240 minutes |
| Cytarabine | 100.0 mg/ml | > 240 minutes |
| Cytovene (Ganciclovir) | 10.0 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 |
| Fulvestrant | 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 |
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
EF
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| Oxaliplatin | 2.0 mg/ml | > 240 minutes |
|---|---|---|
| Paclitaxel | 6.0 mg/ml | > 240 minutes |
| Paraplatin | 10.0 mg/ml | > 240 minutes |
| Pemetrexed | 25.0 mg/ml | > 240 minutes |
| Pertuzumab | 30.0 mg/ml | > 240 minutes |
| Propofol | 10.0 mg/ml | > 240 minutes |
| Raltitrexed | 0.5 mg/ml | > 240 minutes |
| Retrovir | 10.0 mg/ml | > 240 minutes |
| Rituximab | 10.0 mg/ml | > 240 minutes |
| Temsirolimus | 25.0 mg/ml | > 240 minutes |
| Thiotepa | 10.0 mg/ml | 98.7 minutes |
| Topotecan HCl | 1.0 mg/ml | > 240 minutes |
| Trastuzumab | 21.0 mg/ml | > 240 minutes |
| Triclosan | 2.0 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 |
| Zoledronic Acid | 0.8 mg/ml | > 240 minutes |
Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Under the testing conditions of ASTM D6978-05, Gastric Acid was found to have no breakthrough detected up to 240 minutes.
CAUTION: Testing showed breakthrough time of 55.1 minutes with Carmustine and 98.7 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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