(84 days)
This surgical glove is a device made of a neoprene – polyisoprene synthetic material intended to be worn by operating room personnel to protect a surgical wound from contamination.
NUZONE X2 ,powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTM D 3577 - 01a2.
Here's an analysis of the provided text regarding the NUZONE X2 Surgical Glove, focusing on the acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM D 3577 - 01a2 & ASTM D512 for Physical Properties, ASTM F 719-81 & ASTM F 720-81 (86) for Biocompatibility) | Reported Device Performance |
|---|---|
| Physical Properties: Meets requirements for surgical gloves as described by ASTM D 3577-01a2 and other relevant ASTM standards (e.g., ASTM D512). | The product meets the requirements for surgical gloves per ASTM D 3577 – 01a² and ASTM D512. |
| Biocompatibility: Absence of Primary Skin Irritation (ASTM F 719-81). | Primary Skin Irritation test indicates no irritation. |
| Biocompatibility: Absence of Dermal Sensitization (ASTM F 720-81 (86)). | Dermal Sensitization Test indicates no sensitization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the physical property tests or the biocompatibility tests. It only indicates that "Test conducted per ASTM D 3577 – 01a², ASTM D512" and similar for biocompatibility. These ASTM standards typically outline the required sample sizes for such tests.
The data provenance is not specified beyond the fact that the tests were conducted. It's likely these were laboratory tests conducted by the manufacturer or a contracted testing facility, but the country of origin of the raw data/samples is not mentioned. These would be considered prospective tests performed specifically to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the chemical and physical property testing of a medical glove. The "ground truth" for these tests is established by adherence to standardized testing methods (ASTM standards) and objective measurements. There is no mention of experts establishing a subjective "ground truth" for the test set in the context of this device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image analysis by multiple readers). The tests described for this device are objective measurements against established standards.
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. This is a surgical glove, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI performance evaluation was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the objective performance standards defined by the relevant ASTM (American Society for Testing and Materials) standards. These standards specify acceptable ranges or thresholds for physical properties (e.g., tensile strength, elongation, barrier integrity) and the absence of certain biological reactions (irritation, sensitization). The device's performance is directly compared to these objective, scientific benchmarks.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The raw materials used for manufacturing would be subject to quality control, but this is a different concept than a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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TERANG NUSA Sdn Bhd
and the comments of the
510(k) Submission for NUZONE X2 Surgical Glove Powderfree
,-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AUG 2 0 2004
510(k) Summary
| Submitter Name | Terang Nusa Sdn Bhd |
|---|---|
| Submitter Address | 1, Jalan 8Pengkalan Chepa 2 Industrial Zone16100 Kota Bharu,Kelantan, Malaysia. |
| Submitter Telephone | +60 9 7747171 |
| Submitter Fax | +60 9 7747757 |
| Contact Person | LOW, Chin Guan |
| Date of preparation | 09 May 2004 |
| Trade Name | NUZONE X2 |
| Common Name | Sterile Neoprene - Polyisoprene Synthetic surgicalglove, Powderfree, Polymer coated. |
| Classification | Surgeon's Glove |
| Legally marketed device to whichsubstantial equivalence is beingclaimed. | The NUZONE X2, described in this 510(k) issubstantially equivalent to the NUZONE NitrileSurgical Gloves Powderfree that is currentlymarketed. |
| Description of device | NUZONE X2 ,powderfree surgical glove meets therequirements for surgical gloves described by theAmerican Standard for Testing and MaterialASTM D 3577 - 01a2. |
| Intended Use of the device | NUZONE X2 surgical gloves are disposable andsterile devices intended to be worn byhealthcare personnel to prevent crosscontamination between the user and the patientduring procedures. |
510 K Summary ( continued)
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510(k) Submission for NUZONE X2 Surgical Glove Powderfree
| Brief description of non-clinical tests | Test conducted per ASTM D 3577 – 01a², ASTM D512 indicates that the product meet the requirements. |
|---|---|
| Primary Skin Irritation test ASTM F 719-81 and Dermal Sensitization Test ASTM F 720-81 (86) indicates no sensitization or irritation. | |
| Brief description of clinical tests | Not required |
| Conclusion drawn from clinical and non clinical tests | It can be concluded that NUZONE X2 Neoprene - Polyisoprene synthetic powderfree surgical glove will perform according to the performance standards referenced and therefore meets ASTM standards. FDA requirements and labeling claims. This device is substantially equivalent to the currently marketed devices. |
| Additional information deemed necessary by the FDA | None |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three curved lines, resembling a human figure or abstract design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2004
Mr. Chin-Guan Low Director Terang Nusa SDN BHD 1. Jalan 8. Pengkalan Chepa 2 Industrial Zone, 16100 Kota Bharu, MALAYSIA
Re: K041436
Trade/Device Name: Neoprene-Polyisoprene Synthetic Surgical Glove-Powderfree NUZONE X2 Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 6, 2004 Received: August 9, 2004
Dear Mr. Low:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Low
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 modi that I Dr I has made statutes and regulations administered by other Federal agencies. or the Act of any I ederal star s requirements, including, but not limited to: registration 1 ou inust comply with and 807); labeling (21 CFR Part 801); good manufacturing practice tina libing (2) early 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter notification. The FDA finding of substantial equivalence of your device to a premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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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TERANG NUSA San Bhd
510(k) Submission for NUZONE X2 Surgical Glove Powderfree
3. Indication for use Statement
| Submitter | : Terang Nusa Sdn Bhd |
|---|---|
| 510(k) Number | : K041436 |
| Device Name | : Neoprene - Polyisoprene Synthetic Surgical Glove -Powderfree |
| Trade Name | : NUZONE X2 |
Indication for use :
This surgical glove is a device made of a neoprene – polyisoprene synthetic material intended to be worn by operating room personnel to protect a surgical wound from contamination.
Prescription Use (Per 21 CFR 801 Subpart D) ાર
Over the counter X ( 21 CFR 807 Subpart C ) ﺔ ﺍﻟﻤﺮﺍﺟﻊ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR Office of Device Evaluation (ODE)
Ke Muly
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K041436
§ 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).