(293 days)
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. These gloves are tested for use with Chemotherapy Drugs.
Polychloroprene Synthetic Tan Surgical gloves Powder Free
This document is a 510(k) clearance letter for a medical device, specifically the Nuzone X2T surgical gloves. The provided text primarily focuses on the regulatory approval and a table of chemotherapy drug permeation data. It does not describe an AI/ML device or its performance criteria in the typical sense of a diagnostic or predictive model.
Therefore, many of the requested categories are not applicable to this type of medical device clearance.
Here's the breakdown based on the provided information, addressing what is relevant and noting what is not:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for surgical gloves, as indicated by the reference to ASTM D6978-05 for chemotherapy drug testing, usually involve minimum breakthrough times for specific drug concentrations. The study demonstrates the device's performance against these criteria.
| Acceptance Criteria (Minimum Breakthrough Time) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|
| Greater than 5.18 minutes (for Carmustine) | Avg. 5.18 (6.55, 5.95, 3.04) Minutes (Carmustine) |
| Greater than 3.03 minutes (for Thiotepa) | Avg. 3.03 (6.41, 1.63, 1.06) Minutes (Thiotepa) |
| Up to 240 Minutes (for other listed drugs) | Up to 240 Minutes (for the remaining 8 drugs) |
Note: The exact "acceptance criteria" for Carmustine and Thiotepa are not explicitly stated as a minimum threshold in the document, but rather the reported average breakthrough times are given. For the other drugs, "Up to 240 Minutes" is both the reported performance and implies that permeation did not occur within that timeframe, which is a common acceptance criterion for chemotherapy gloves. The phrasing "Please note that the following drugs have extremely low permeation times Carmustine (BCNU) of 5.18 and Thiotepa of 3.03 minutes" serves as a warning, indicating these are critical values that users should be aware of.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size (e.g., number of gloves) used for testing each chemotherapy drug.
- Data Provenance: Not specified in the provided text, but testing based on ASTM standards is typically conducted in a laboratory setting. This would be prospective testing of new glove samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a physical product (surgical glove) test, not an AI/ML diagnostic or image-based assessment requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement of drug permeation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a laboratory test, not an expert-based adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. No AI component or human reader study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. No algorithm or AI component is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is established by physical laboratory measurements of chemotherapy drug permeation through the glove material, following the methodology described in ASTM D6978-05.
8. The sample size for the training set
- Not Applicable. No AI/ML model or training set is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. No AI/ML model or training set is mentioned.
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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.
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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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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.
§ 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).