(59 days)
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No
The document describes surgical gloves and their testing against chemotherapy drugs, with no mention of AI or ML technology.
No
The device is a surgical glove intended as a barrier, not to treat or cure a disease or condition.
No
Explanation: The device is a surgical glove intended to provide a barrier against infectious materials and chemotherapy drugs, not to diagnose medical conditions.
No
The device described is a physical glove, not a software application. The testing and performance studies relate to the material properties and barrier function of the glove, 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 to provide a barrier on the hands in surgical settings against infectious materials and chemotherapy drugs. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: While a device description is not provided, the intended use clearly describes a glove, which is a physical barrier device.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition. The testing described is for the glove's resistance to permeation, not for diagnosing anything.
- Testing Method: The testing described (ASTM D6978-05) is a standard for assessing the barrier properties of gloves against chemicals, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
The Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
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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
hands
Indicated Patient Age Range
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Intended User / Care Setting
surgical settings
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 Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Summary for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue):
- Carmustine (3.3 mg/ml): 13.4 minutes
- Cisplatin (1.0 mg/ml): >240 minutes
- Cyclophosphamide (20.0 mg/ml): >240 minutes
- Dacarbazine (10.0 mg/ml): >240 minutes
- Doxorubicin Hydrochloride (2.0 mg/ml): >240 minutes
- Etoposide (20.0 mg/ml): >240 minutes
- Fluorouracil (50.0 mg/ml): >240 minutes
- Methotrexate (25.0 mg/ml): >240 minutes
- Mitomycin C (0.5 mg/ml): >240 minutes
- Paclitaxel (6.0 mg/ml): >240 minutes
- Thiotepa (10.0 mg/ml): 15.2 minutes
- Vincristine Sulfate (1.0 mg/ml): >240 minutes
Please note that Carmustine and Thiotepa have extremely low permeation times of 13.4 minutes and 15.2 minutes respectively.
Summary for Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural):
- Carmustine (3.3 mg/ml): 14.5 minutes
- Cisplatin (1.0 mg/ml): >240 minutes
- Cyclophosphamide (20.0 mg/ml): >240 minutes
- Dacarbazine (10.0 mg/ml): >240 minutes
- Doxorubicin Hydrochloride (2.0 mg/ml): >240 minutes
- Etoposide (20.0 mg/ml): >240 minutes
- Fluorouracil (50.0 mg/ml): >240 minutes
- Methotrexate (25.0 mg/ml): >240 minutes
- Mitomycin C (0.5 mg/ml): >240 minutes
- Paclitaxel (6.0 mg/ml): >240 minutes
- Thiotepa (10.0 mg/ml): 23.5 minutes
- Vincristine Sulfate (1.0 mg/ml): >240 minutes
Please note that Carmustine and Thiotepa have extremely low permeation times of 13.4 minutes and 15.2 minutes respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 1, 2020
Hartalega SDN. BHD. % Nurul Kong Quality Assurance Senior Manager Hartalega SDN. NHD NO. 7, Kawasan Perusahaan Suria Bestari Jaya, Selangor 45600 Malaysia
Re: K200897
Trade/Device Name: Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: March 27, 2020 Received: April 3, 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.
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 (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 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.
For 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) K200897
Device Name
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue)
Indications for Use (Describe)
The Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 13.4 |
| 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) | 15.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 13.4 minutes and 15.2 minutes respectively.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
Indications for Use
510(k) Number (if known) K200897
Device Name
Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
Indications for Use (Describe)
The Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 14.5 |
| 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) | 23.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 13.4 minutes and 15.2 minutes respectively.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."