(221 days)
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Not Found
No
The device description and performance studies focus on the material properties and chemical resistance of examination gloves, with no mention of AI or ML technologies.
No
The device, examination gloves, is intended to prevent contamination, not to treat or alleviate a medical condition.
No
Explanation: The device is described as examination gloves used to prevent contamination, not to diagnose a medical condition.
No
The device is described as "Black Non Sterile Powder Free Nitrile Examination Gloves," which are physical gloves worn on the hand. The description focuses on the material and intended use as a barrier, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a disposable device worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier device for personal protection.
- Device Description: The description reinforces the intended use as a protective glove.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition. The testing performed is related to the glove's barrier properties against certain substances, not its ability to diagnose anything.
IVD devices are used to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device is a physical barrier.
N/A
Intended Use / Indications for Use
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).
Product codes
LZA, LZC, ODO, OPJ
Device Description
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
worn on the examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purposes / Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested for use with chemotherapy drugs, with chloroquine, cyclosporin A, retrovir, gastric acid and fentanyl citrate in accordance with ASTM D6978-05(2019).
Key results:
Chemotherapy drugs: Bleomycin Sulfate (> 240 mins), Busulfan (> 240 mins), Carboplatin (> 240 mins), Carmustine (BCNU) (13.2 mins), Cisplatin (> 240 mins), Cyclophosphamide (Cytoxan) (> 240 mins), Cytarabine (Cytosine) (> 240 mins), Dacarbazine (> 240 mins), Daunorubicin HCl (> 240 mins), Docetaxel (> 240 mins), Doxorubicin HCl (> 240 mins), Epirubicin HCl (Ellence) (> 240 mins), Etoposide (Toposar) (> 240 mins), Fludarabine (> 240 mins), Fluorouracil (> 240 mins), Gemcitabine (Gemzar) (> 240 mins), Idarubicin HCl (> 240 mins), Ifosfamide (> 240 mins), Irinotecan (> 240 mins), Mechlorethamine HCl (> 240 mins), Melphalan (> 240 mins), Methotrexate (> 240 mins), Mitomycin C (> 240 mins), Mitoxantrone HCl (> 240 mins), Oxaliplatin (> 240 mins), Paclitaxel (> 240 mins), Paraplatin (> 240 mins), Rituximab (> 240 mins), Thiotepa (34.7 mins), Topotecan HCl (> 240 mins), Trisenox (Arsenic Trioxide) (> 240 mins), Velcade (Bortezomib) (> 240 mins), Vincristine Sulfate (> 240 mins).
Non-chemotherapy drugs: Chloroquine (> 240 mins), Cyclosporin A (> 240 mins), Retrovir (> 240 mins).
Fentanyl Permeation: no breakthrough detected up to 240 minutes.
Gastric Acid Permeation: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Breakthrough Detection Time in Minutes
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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.
1
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
2
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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