(150 days)
Not Found
Not Found
No
The 510(k) summary describes a surgical glove and its testing against chemotherapy drugs. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on chemical permeation testing, not algorithmic performance.
No
This device is a surgical glove intended to protect a surgical wound from contamination and to be used against chemotherapy drugs, not to provide therapy or treatment for a disease or condition.
No
Explanation: The device is a surgical glove intended for protection, not for diagnosing medical conditions. Its function is to prevent contamination and resist chemotherapy drugs, not to identify or monitor diseases.
No
The device is a physical surgical glove, not a software application. The summary describes a tangible product and its performance characteristics related to chemical resistance.
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 by operating personnel to protect a surgical wound from contamination and for use with chemotherapy drugs. This is a protective barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly defines the device's function.
- Mentions image processing, AI, DNN, or ML: None of these are mentioned, which are often associated with more complex diagnostic devices.
- Input Imaging Modality, Anatomical Site, Indicated Patient Age Range: These are all "Not Applicable," further indicating it's not a diagnostic device that interacts with the patient's body for diagnostic purposes.
- Intended User / Care Setting: The intended user is "operating personnel," and the care setting is implied to be a surgical environment.
- Performance Studies: The performance studies focus on the glove's resistance to chemotherapy drugs, which is a measure of its protective barrier function, not its ability to diagnose a condition.
- Key Metrics: The key metrics are "Minimum Breakthrough Detection Time," which relates to the glove's barrier properties.
In Vitro Diagnostics (IVDs) are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drugs have low permeation times: Carmusiine (BCNU) 3.3 mg/ml 12.5 minutes; Thiotepa 10.0 mg/ml 13.6 minutes. Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
Product codes
KGO, LZC
Device Description
Made of natural rubber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating personnel
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)
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Key results for minimum breakthrough detection time in minutes:
- Carmustine (BCNU) (3.3 mg/ml): 12.5
- Cisplatin (1 mg/ml): > 240
- Cyclophosphamide (Cytoxan) (20.0 mg/ml): > 240
- Dacarbazine (10 mg/ml): > 240
- Doxorubicin HCI (2.0 mg/ml): > 240
- Etoposide (20.0 mg/ml): > 240
- Fluorouracil (50.0 mg/ml): > 240
- Methotrexate (25 mg/ml): > 240
- Mitomycin C (0.5 mg/ml): > 240
- Paclitaxel (6.0 mg/ml): > 240
- Thiotepa (10.0 mg/ml): 13.6
- Vincristine Sulfate (1.0 mg/ml): > 240
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum 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
§ 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).
0
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.
May 26, 2022
Hartalega NGC SDN. BHD. Nurul Kong Deputy General Manager-Quality Assurance No. 1 Persiaran Tanjung Sepang, Kawasan Perindustrian Tanjung 43900 Malaysia
Re: K214074
Trade/Device Name: Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-powdered surgeon's glove Regulatory Class: Class I. reserved Product Code: KGO, LZC Dated: April 8, 2022 Received: April 14, 2022
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 (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 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.
Bifeng Qian, M.D., Ph.D. Acting 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) K214074
Device Name
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs 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 (BCNU) (3.3 mg/ml) | 12.5 |
| Cisplatin (1 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10 mg/ml) | > 240 |
| Doxorubicin HCI (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 13.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that the following drugs have low permeation times: Carmusiine (BCNU) 3.3 mg/ml 12.5 minutes; Thiotepa 10.0 mg/ml 13.6 minutes. Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
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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