(293 days)
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No
The summary describes a surgical glove and its performance against chemotherapy drugs, with no mention of AI or ML technology.
No
Explanation: A therapeutic device aims to treat, mitigate, or cure a disease or injury. This device, a surgical glove, serves as a protective barrier to prevent contamination, which is a preventative and protective function, not a therapeutic one.
No
Explanation: The device is a surgical glove intended to protect a surgical wound from contamination, not to diagnose a medical condition or disease. Its performance studies focus on breakthrough detection time with chemotherapy drugs, which relates to its protective function, not diagnostic capabilities.
No
The device is a physical surgical glove made of synthetic rubber, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by operating room personnel. This is a barrier function, not a diagnostic function performed on a sample taken from the body.
- Device Description: It's a surgical glove, a physical barrier.
- Performance Studies: The performance studies focus on the glove's ability to resist penetration by chemotherapy drugs, which is related to its barrier function and safety for the user, not a diagnostic test.
- Key Metrics: The key metric is "Breakthrough Detection Time," which measures the time it takes for a substance to penetrate the glove, again related to its barrier properties.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical glove does not perform any such function.
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. The lubricating or dusting powder used in the glove is excluded.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Polychloroprene Synthetic Tan Surgical gloves Powder Free
These gloves are tested for use with Chemotherapy Drugs.
Testing based on ASTM D6978-05
DRUG: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), Breakthrough Detection Time: Avg. 5.18 (6.55, 5.95, 3.04) Minutes
DRUG: Cisplatin 1.0 mg/ml (1,000 ppm), Breakthrough Detection Time: Up to 240 Minutes
DRUG: Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm), Breakthrough Detection Time: Up to 240 Minutes
DRUG: Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm), Breakthrough Detection Time: Up to 240 Minutes
DRUG: Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm), Breakthrough Detection Time: Up to 240 Minutes
DRUG: Etoposide (Toposar) 20.0 mg/ml (20,000 ppm), Breakthrough Detection Time: Up to 240 Minutes
DRUG: Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm), Breakthrough Detection Time: Up to 240 Minutes
DRUG: Fluorouracil 50.0 mg/ml (50,000 ppm), Breakthrough Detection Time: Up to 240 Minutes
DRUG: Thiotepa 10.0 mg/ml (10,000 ppm), Breakthrough Detection Time: Avg. 3.03 (6.41, 1.63, 1.06) Minutes
DRUG: Vincristine Sulfate 50.0 mg/ml (50,000 ppm), Breakthrough Detection Time: Up to 240 Minutes
Please note that the following drugs have extremely low permeation times Carmustine (BCNU) of 5.18 and Thiotepa of 3.03 minutes.
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)
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
DEC - 7 2011
Mr. Robert Hill Regulatory Manager Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2 Ind. Zone Kota Bharu Kelantan MALAYSIA 16100
Re: K110698
Trade/Device Name: Nuzone X2T Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: December 5, 2011 Received: December 5, 2011
Dear Mr. Hill:
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
Page 2 - Mr. Hill
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony D. mater
Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ·
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Image /page/2/Picture/0 description: The image shows the words "TERANG NUSA" in a bold, sans-serif font. To the right of the words is a stylized compass rose or star-like symbol. The text and symbol are both in black, contrasting with the white background.
Indications for Use
510(k) Number: K110698
Device Name: Nuzone X2T
Description: Polychloroprene Synthetic Tan Surgical gloves Powder Free
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. The lubricating or dusting powder used in the glove is excluded.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________
. ------
Shila H. Murphy, MD to B. Blythe Thorne Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Page 1 of 2
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TERANG NUSA
510(k) Number: Kl10698 Device Name: Nuzone X2T
Continued:
These gloves are tested for use with Chemotherapy Drugs.
Testing based on ASTM D6978-05
| DRUG | Breakthrough Detection Time |
|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | Avg. 5.18 (6.55, 5.95, 3.04) Minutes |
| Cisplatin 1.0 mg/ml (1,000 ppm) | Up to 240 Minutes |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) | Up to 240 Minutes |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | Up to 240 Minutes |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | Up to 240 Minutes |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | Up to 240 Minutes |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | Up to 240 Minutes |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | Up to 240 Minutes |
| Thiotepa 10.0 mg/ml (10,000 ppm) | Avg. 3.03 (6.41, 1.63, 1.06) Minutes |
| Vincristine Sulfate 50.0 mg/ml (50,000 ppm) | Up to 240 Minutes |
Please note that the following drugs have extremely low permeation times Carmustine (BCNU) of 5.18 and Thiotepa of 3.03 minutes.