(131 days)
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No
The summary describes a standard patient examination glove and its testing against chemical permeation, with no mention of AI or ML technologies.
No
This device, a patient examination glove, is intended to prevent contamination between patient and examiner, primarily functioning as a barrier, not to treat or alleviate a disease or condition.
No
The device is a patient examination glove, which is a barrier device used to prevent contamination between a patient and an examiner. Its function is protective, not diagnostic. While it's tested for permeation by chemotherapy drugs, this testing relates to its protective barrier performance, not to diagnosing any medical condition.
No
The device is a physical glove, not software. The description clearly outlines a tangible product made of nitrile.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a "patient examination glove" intended to be "worn on the examiner's hand to prevent contamination between patient and examiner." This is a physical barrier device used for protection, not a test performed on a biological sample.
- Testing: While the gloves are tested for permeation by chemotherapy drugs and Fentanyl Citrate, this testing is to assess the glove's barrier properties, not to diagnose or monitor a patient's condition.
Therefore, this device falls under the category of a medical device, specifically a personal protective equipment (PPE), rather than an in vitro diagnostic device.
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
LZA, LZC, OPJ, QDO
Device Description
Powder Free Nitrile Patient Examination Glove, Blue 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
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Intended User / Care Setting
examiner
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 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. The minimum breakthrough detection times for various chemotherapy drugs ranged from 26.2 minutes (Carmustine (BCNU)) to >240 minutes. For Fentanyl Citrate Injection (100 mcg/2ml), the minimum breakthrough detection time was >240 minutes, and for Simulated Gastric Acid Fluid, it was also >240 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum Breakthrough Detection Time in Minutes for various chemotherapy drugs, Fentanyl Citrate, and Simulated Gastric Acid Fluid.
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.
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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.
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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).
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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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 15, 2023
Kossan International Sdn Bhd3 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: K223375
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Blue 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, OPJ, QDO Dated: January 31, 2023 Received: February 2, 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 (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) K223375
Device Name
Powder Free Nitrile Patient Examination Glove, Blue 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 |
|---|---|
| Bendamustine HCI (Treanda) (5 mg/ml) | >240 |
| Bleomycin Sulfate (15 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | 26.2 |
| Cetuximab (Erbitux) (2 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cladribine (1 mg/ml) | >240 |
| Cyclosporin A (100 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Cytovene (Ganciclovir) (10 mg/ml) | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | >240 |
| Daunorubicin HCI (5 mg/ml) | >240 |
| Decitabine (5 mg/ml) | >240 |
| Docetaxel (Taxotere) (20 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Epirubicin HCI (Ellence) (2 mg/ml) | >240 |
| Etoposide (20 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Idarubicin HCI (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan (20 mg/ml) | >240 |
| Mechlorethamine HCI (1 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Oxaliplatin (5 mg/ml) | >240 |
| Paclitaxel (Taxol) (6 mg/ml) | >240 |
| Pemetrexed (25 mg/ml) | >240 |
| Raltitrexed (0.5 mg/ml) | >240 |
| Retrovir (Zidovudine) (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Thiotepa (10 mg/ml) | 59.1 |
| Topotecan (1 mg/ml) | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | >240 |
| Velcade (Bortezomib) (1 mg/ml) | >240 |
| Vidaza (Azacytidine) (25 mg/ml) | >240 |
| Vinblastine (1 mg/ml) | >240 |
| Vincristine Sulfate (1 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |
| Zoledronic Acid (1 mg/25ml) | >240 |
3
Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 26.2 and 59.1 minutes respectively. Warning: Do Not Use with Carmustine (BCNU)
Caution: Thiotepa has low permeation times of 59.1 minutes
| Opioid and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Simulated Gastric Acid Fluid | Minimum Breakthrough Detection Time in Minutes |
Simulated Gastric Acid Fluid
240
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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