(119 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored). Non-Sterile, meets all of the requirements of ASTM D 6319-10.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non-Colored). Non-Sterile" device:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-holes | ASTM D 5151-06ASTM D 6319-10 | Meets |
| Powder Free Residue | ASTM D 6124-06ASTM D 6319-10 | Meets |
| Biocompatibility: | ||
| Dermal Sensitization | ISO 10993-10:2010 | Not a contact skin sensitizer |
| Primary Skin Irritation | 16 CFR Part 1500 | Not a primary skin irritant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Biocompatibility). It only states that the device "meets" the referenced ASTM and ISO standards. These standards themselves would define the required sample sizes for their respective tests.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that Kossan Latex Industries is a Malaysian company and they are claiming compliance with international standards, it's highly probable the testing was conducted by or overseen by the manufacturer, potentially in Malaysia or by certified testing labs. The document implies these are prospective tests conducted to demonstrate compliance for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a patient examination glove, and its performance is evaluated against objective, measurable, and standardized technical specifications (ASTM, ISO, CFR standards). Ground truth, in the sense of expert consensus, is typically relevant for interpretative tasks, such as diagnostic imaging analysis or clinical assessments, which is not the case for this product.
4. Adjudication Method for the Test Set
This is not applicable. The performance evaluations are based on direct measurement and laboratory testing against pre-defined, quantitative standards, not on subjective interpretations requiring adjudication.
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
This is not applicable. This submission is for a physical medical device (patient examination glove), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable for the same reasons as point 5. There is no algorithm involved with this device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is the objective measurement and testing results against the established quantitative criteria defined in the referenced standards (ASTM D 6319-10, ASTM D 5151-06, ASTM D 6124-06, ISO 10993-10:2010, and 16 CFR Part 1500). For example:
- Dimensions: Measured directly against the specified ranges in ASTM D 6319-10.
- Physical Properties: Tensile strength, elongation, etc., measured according to methods outlined in ASTM D 6319-10.
- Freedom from pin-holes: Water leak test (ASTM D 5151-06) or air leak test methods.
- Powder Free Residue: Measured gravimetrically as per ASTM D 6124-06.
- Biocompatibility: Standardized biological assays (dermal sensitization, primary skin irritation) with predefined endpoints for "not a sensitizer" or "not an irritant."
8. The Sample Size for the Training Set
This is not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI. Performance is based on physical testing of manufactured samples.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as point 8.
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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)
0CT 2 0 2011
대한민국 대학
FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information
1.0 Submitter:
Kossan Latex Industries (M) Sdn Bhd Lot 6129, Jalan Haji Abdul Manan, Batu 5 %, Jalan Meru, Klang, 41050 Selangor, Malaysia
| Telephone No.: | +603 3392 3088 |
|---|---|
| Fax No.: | +603 3291 0584 |
2.0 Contact Person:
| Contact: | Ms S F Cho |
|---|---|
| Telephone No.: | +603 3392 3088 |
| Fax No.: | +603 3291 0584 |
3.0 Preparation Date: 30 September 2011
4.0 Name of Device:
Trade Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non- Colored). Non-Sterile. Common Name: Powder-Free Nitrile Patient Examination Glove Classification Name: Patient Examination Glove (21 CFR Part 880.6250)
5.0 Identification of the Legally Marketed Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile; Class I Patient Examination Gloves, Nitrile-80LZA, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Predicate Device: K062764, Powder Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored, Non-Sterile. Tested For Use with Chemotherapy Drugs
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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)
Description of Device: 6.0
.
Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored). Non-Sterile, meets all of the requirements of ASTM D 6319-10.
7.0 Intended Use of the Device:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summary of the Technological Characteristics of the Device: 8.0
Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Non-Sterile, possesses the following technological characteristic (as Colored). compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-holes | ASTM D 5151-06 | Meets |
| ASTM D 6319-10 | Meets | |
| Powder Free Residue | ASTM D 6124-06 | Meets |
| ASTM D 6319-10 | Meets | |
| Biocompatibility | Dermal Sensitization(as per ISO 10993-10:2010) | Not a contact skin sensitizer |
| Primary SkinIrritation Test(as per 16 CFR Part1500) | Not a primary skin irritant |
Substantial Equivalent Based on Assessment of Non-Clinical Performance 9.0 Data
The performance test data that support a determination of substantial equivalence are described above.
Substantial Equivalent Based on Assessment of Clinical Performance Data 10.0
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K1
11.0 Conclusion
lt can be concluded that the Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored). Non-Sterile, is safe and effective for use and will perform according to the glove performance standards referenced in Section 8.0 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.
Consequently, this device is substantially equivalent to current marketed devices. This summary will include any other information reasonably deemed necessary by the FDA.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 emblem featuring three curved lines that resemble a human figure or a symbol representing health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Ms. Cho Sow Fong RA Manager Kossan Latex Industries (M) SDN BHD Lot 6129, Jalan Haii Abdul Manan, Batu 5 ¼, Jalan Meru, Klang, 41050 Selangor, Malaysia
Re: K111772
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored and
White (Non-Colored). Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 30, 2011 Received: October 5, 2011
Dear Ms. Fong:
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 - Ms. Fong
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 (OS) 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 yours,
Anthony D. Minton
Anthony D. Watson, B.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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Inuncations 101 USC
1777
510(k) Number (if known):
| Device Name: | Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile. |
|---|---|
| -------------- | ---------------------------------------------------------------------------------------------------- |
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
x Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF )NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Elijabeth S. Clamur WMS
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111772
Page I of
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.