(91 days)
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No
The device description and performance studies focus on the physical properties and chemical resistance of examination gloves, with no mention of AI or ML.
No
A patient examination glove is a barrier device intended to prevent contamination and does not provide therapeutic benefit to the patient.
No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is protective, not diagnostic.
No
The device description clearly identifies the device as a physical examination glove, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Intended Use: The intended use of this device is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier device used externally on the examiner.
- Lack of Specimen Examination: The device does not examine any specimens derived from the human body. Its function is to create a physical barrier.
- Testing for Permeation: The testing mentioned (ASTM D6978-05) is related to the glove's ability to prevent the passage of substances through it, not to analyze or diagnose anything from a patient specimen.
Therefore, based on the provided information, this device is a medical glove used for protection and contamination prevention, not an IVD.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Chemotherapy Drug Permeation Testing:
- Carmustine (BCNU) (3.3 mg/ml): Pink 12.4 min, Orange 11.7 min, Blue 10.1 min, Black 14.4 min.
- Cisplatin (1.0 mg/ml): >240 min for all tested colors.
- Cyclophosphamide (Cytoxan) (20.0 mg/ml): >240 min for all tested colors.
- Cytarabine (100 mg/ml): Pink >240 min, Orange Not tested, Blue >240 min, Black >240 min.
- Dacarbazine (DTIC) (10.0 mg/ml): >240 min for all tested colors.
- Doxorubicin Hydrochloride (2.0 mg/ml): >240 min for all tested colors.
- Etoposide (20.0 mg/ml): >240 min for all tested colors.
- Fluorouracil (50.0 mg/ml): >240 min for all tested colors.
- Ifosfamide (50.0 mg/ml): Pink >240 min, Orange Not Tested, Blue >240 min, Black >240 min.
- Methotrexate (25.0 mg/ml): Pink >240 min, Orange Not Tested, Blue >240 min, Black >240 min.
- Mitomycin C (0.5 mg/ml): Pink >240 min, Orange Not Tested, Blue >240 min, Black >240 min.
- Mitoxantrone (2.0 mg/ml): Pink >240 min, Orange Not Tested, Blue >240 min, Black >240 min.
- Paclitaxel (Taxol) (6.0 mg/ml): >240 min for all tested colors.
- Thiotepa (10.0 mg/ml): Pink 43.1 min, Orange 43.2 min, Blue 30.2 min, Black 29.2 min.
- Vincristine Sulfate (1.0 mg/ml): Pink >240 min, Orange Not Tested, Blue >240 min, Black >240 min.
Opioid Drug Permeation Testing:
- Fentanyl Citrate Injection (100 mcg/2ml): >240 min for all tested colors.
- Xylazine HCl (100 mg/ml): Pink Not Tested, Orange >240 min, Blue >240 min, Black >240 min.
Simulated Gastric Acid Permeation Testing:
- Simulated Gastric Acid: >240 min for all tested colors.
Key Results: Carmustine (BCNU) and Thiotepa exhibited low permeation times. A warning is issued: "Do Not Use with Carmustine (BCNU) and Thiotepa."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum Breakthrough Detection Time in 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.
November 14, 2023
Kossan International Sdn Bhd Cho Sow Fong Senior Manager Regulatory Affairs Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 3/4, Jalan Kapar Klang, Selangor 42100 Malaysia
Re: K232461
Trade/Device Name: Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO, OPJ Dated: August 11, 2023 Received: August 15, 2023
Dear Cho Sow Fong:
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
1
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.
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 OS 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 (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 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).
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Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis
Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis
Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | Pink | Orange | Blue | Black |
|---|---|---|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 12.4 | 11.7 | 10.1 | 14.4 | |
| Cisplatin (1.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Cytarabine(100 mg/ml) | >240 | Not tested | >240 | >240 | |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Etoposide (20.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Fluorouracil (50.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Ifosfamide (50.0 mg/ml) | >240 | Not Tested | >240 | >240 | |
| Methotrexate (25.0 mg/ml) | >240 | Not Tested | >240 | >240 | |
| Mitomycin C (0.5 mg/ml) | >240 | Not Tested | >240 | >240 | |
| Mitoxantrone (2.0 mg/ml) | >240 | Not Tested | >240 | >240 | |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 | >240 | >240 | >240 | |
| Thiotepa (10.0 mg/ml) | 43.1 | 43.2 | 30.2 | 29.2 | |
| Vincristine Sulfate (1.0 mg/ml) | >240 | Not Tested | >240 | >240 |
Please note that Carmustine (BCNU) and Thiotepa has low permeation times.
Warning: Do Not Use with Carmustine (BCNU) and Thiotepa
| Opioid Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |||
|---|---|---|---|---|
| Pink | Orange | Blue | Black | |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 | >240 |
| Xylazine HCl (100 mg/ml) | Not Tested | >240 | >240 | >240 |
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| Simulated Gastric Acid | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| ------------------------ | ------------------------------------------------ |
| Pink | Orange | Blue | Black | |
|---|---|---|---|---|
| Simulated Gastric Acid | >240 | >240 | >240 | >240 |
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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