(113 days)
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No
The summary describes a surgical glove and its testing for chemotherapy drug resistance, with no mention of AI or ML.
No
The Surgeons glove is intended to protect a surgical wound from contamination, which is a preventative measure, not a therapeutic intervention to treat a disease or condition.
No
The device is described as a "Surgeons glove" intended to protect a surgical wound from contamination and for use with chemotherapy drugs. Its function is protective and not for diagnosing a condition or disease.
No
The device is a physical glove made of synthetic rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: This device is a surgical glove, intended to be worn by operating room personnel to protect a surgical wound from contamination. Its function is a physical barrier and protection, not the analysis of biological specimens.
- Intended Use: The intended use clearly states its purpose is protection during surgery, not diagnostic testing.
- Performance Studies: The performance studies focus on the glove's barrier properties against chemotherapy drugs, which is relevant to its protective function, not diagnostic accuracy.
Therefore, based on the provided information, this surgical glove falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This Surgeons glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves are tested for use with Chemotherapy Drugs. Testing based on ASTM D6978-05.
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
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel
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)
Testing based on ASTM D6978-05. The minimum breakthrough detection time in minutes for various chemotherapy drugs was provided. Carmustine (BCNU) 3.3 mg/ml (3,300ppm) had a minimum breakthrough detection time of 30.6 minutes (Specimen 1/2/3: 30.6, 30.6, 30.8). Thiotepa 10.0 mg/ml (10,000ppm) had a minimum breakthrough detection time of 31.2 minutes (Specimen 1/2/3: 31.2, 60.8, 61.3). Other listed drugs (Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, Etoposide, Paclitaxel, Fluorouracil, Vincristine Sulfate) showed breakthrough times of up to 240 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum Breakthrough Detection Time
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2015
Terang Nusa, Sdn. Bhd. Mr. Robert Hill Regulatory Director 1. Jalan 8 Pengkalan Chepa 2 Industrial Zone 16100 Kota Bharu MALAYSIA
Re: K150973
Trade/Device Name: NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's glove Regulatory Class: I Product Code: KGO, LZC Dated: July 1, 2015 Received: July 5, 2015
Dear Mr. Hill:
This letter corrects our substantially equivalent letter of August 4, 2015.
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150973
Device Name
NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
This Surgeons glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves are tested for use with Chemotherapy Drugs. Testing based on ASTM D6978-05
| DRUG | Minimum Breakthrough Detection Time
(Specimen 1/2/3)
Minutes |
|--------------------------------------------------|--------------------------------------------------------------------|
| Carmustine (BCNU), 3.3 mg/ml (3,300ppm) | 30.6 (30.6, 30.6, 30.8) |
| Cisplatin, 1.0 mg/ml (1,000ppm) | Up to 240 |
| Cyclophosphamide (Cytoxan), 20 mg/ml (20,000ppm) | Up to 240 |
| Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | Up to 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml (2,000ppm) | Up to 240 |
| Etoposide (Toposar), 20.0 mg/ml (20,000ppm) | Up to 240 |
| Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | Up to 240 |
| Fluorouracil, 50.0 mg/ml (50,000ppm) | Up to 240 |
| Thiotepa, 10.0 mg/ml (10,000ppm) | 31.2 (31.2, 60.8, 61.3) |
| Vincristine Sulfate, 1.0 mg/ml (1,000ppm) | Up to 240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 30.6 Thiotepa 31.2
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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