(58 days)
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No
The document describes a physical medical device (examination gloves) and its testing against chemical permeation. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a glove intended to prevent contamination, not to treat a condition or disease.
No
The device is described as a glove worn on the hand to prevent contamination, and its performance studies are related to permeation by chemotherapy drugs and fentanyl citrate, not to diagnose a medical condition.
No
The device is a physical glove, not software. The description clearly states it is a "non-sterile disposable device intended for medical purpose that is worn on the examiner's hand".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier function for personal protection and infection control.
- Device Description: The description reinforces the function as a barrier worn on the hand.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis on a specimen.
- Testing: The testing described (permeation by chemotherapy drugs and fentanyl citrate) relates to the protective barrier function of the glove, not to the analysis of a biological specimen.
Therefore, this device is a medical glove intended for personal protection and infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
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, QDO
Device Description
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
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 (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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/0 description: The image contains 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.
August 5, 2020
Hartalega Ngc Sdn. Bhd. Nurul Kong Senior Manager- Ouality Assurance Kawasan Perindustrian Tanjung Sepang, 43900 My
Re: K201530
Trade/Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: June 4, 2020 Received: June 8, 2020
Dear Nurul Kong:
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.
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
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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 (OS) 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 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).
Sincerely,
CAPT Elizabeth Claverie, M.S. 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) K201530
Device Name
Nittile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey)
Indications for Use (Describe)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
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 |
|---|---|
| Carmustine (3.3 mg/ml) | 12.9 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 45.0 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Azacytidine (25.0 mg/ml) | >240 |
| Carboplatin (10.0 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Epirubicin (2.0 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan (20 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oncovin (1.0 mg/ml) | >240 |
| Oxaliplatin (5 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |
| Please note that Carmustine and Thiotepa have extremely low permeation times of 12.9 minutes and 45.0 minutes respectively. | |
| Warning: Do not use with Carmustine. | |
| Warning: Do not use with Thiotepa. | |
| Fentanyl Citrate and Concentration | |
| Fentanyl Citrate Injection (100 mcg/2ml) | Minimum Breakthrough Detection Time in Minutes |
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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