(102 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 Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will meet all the current specification for ASTM D6319.
The provided document describes the acceptance criteria and a study that proves a medical device, specifically "Powder Free Nitrile Examination Gloves," meets those criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319 – 00a (2005) | Meets |
| Physical Properties | ASTM D 6319 – 00a (2005) | Meets |
| Freedom from pin-holes | ASTM D 5151 – 99 (2006) & ASTM D 6319 – 00a (2005) | Meets |
| Powder Free Residue | ASTM D 6124 – 06 & ASTM D 6319 – 00a (2005) | Meets |
| Biocompatibility (Dermal Sensitization) | Dermal Sensitization (as per ASTM F720-81) | Not a contact skin sensitizer |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation Test (as per 16CFR Part1500) | Not a primary skin irritant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for each test. However, it indicates that the tests conform to ASTM standards (D6319, D5151, D6124, F720) and 16CFR Part 1500, which inherently define the sample sizes and methodologies for these tests.
- Data Provenance: The tests are conducted by the manufacturer, IDEAL QUALITY SDN. BHD., located in Malaysia. The type of study (retrospective or prospective) is not explicitly stated, but given the nature of product testing for regulatory clearance, it would be prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the testing of a medical glove, which relies on objective, standardized physical, chemical, and biological tests rather than subjective human interpretation of images or symptoms. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic AI is not applicable here. The "ground truth" is established by the defined test methods themselves and the laboratories performing these tests.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are objective and based on established industry standards and regulations. There is no mention of an adjudication process among human readers or experts for the results of these physical and biological tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret cases, and the AI's impact on their performance is measured. For a physical device like an examination glove, this is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. The device is a physical product (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used is based on objective, standardized test methods and criteria defined by:
- ASTM International standards (e.g., D6319, D5151, D6124, F720)
- U.S. Code of Federal Regulations (e.g., 16CFR Part 1500 for skin irritation).
These standards dictate the acceptable limits for various physical properties, freedom from defects, and biocompatibility, which constitute the "ground truth" for the device's performance.
8. The Sample Size for the Training Set
This question is not applicable. The device is a manufacturing product (gloves) and does not involve AI or machine learning models that require a "training set."
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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FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information
Date: 12 February 2011
1.0 Submitter:
IDEAL QUALITY SDN. BHD. Lot 2796, 17 1/2 Miles, Jalan Kapar, 42200 Klang, Selangor Darul Ehsan, Malaysia.
Telephone No.: +603 3291 0516 Fax No.: +603 3291 0584
2.0 Contact Person:
| Contact: | Mr. SH TAN |
|---|---|
| E-mail: | shtan@ideal-quality.com |
| Telephone No.: | +603 3291 0516 |
| Fax No.: | +603 3291 0584 |
3.0 Name of Device:
| Trade Name: | Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non-Sterile |
|---|---|
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove. |
4.0 Identification of The Legally Marketed Device:
The Powder Free Nitrile Examination Gloves, White (non colored) or Blue (colored), Non-Sterile, Class I Patient Examination gloves, 80LZA, meets all of the requirements of ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application.
Predicate Device: K060771, Powder Free Nitrile Examination Glove, White (Non-Colored) and Blue Colored
5.0 Description of Device:
Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will meet all the current specification for ASTM D6319.
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IDEAL QUALITY SDN. BHD. (Company No.404964-P)
6.0 Intended Use of the Device:
Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile.
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.
7.0 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.
8.0 Summary of The Technological Characteristics of The Device:
Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319 – 00a(2005) | Meets |
| Physical Properties | ASTM D 6319 – 00a(2005) | Meets |
| Freedom from pin-holes | ASTM D 5151 – 99 (2006)ASTM D 6319 – 00a(2005) | MeetsMeets |
| Powder Free Residue | ASTM D 6124 – 06ASTM D 6319 – 00a(2005) | MeetsMeets |
| Biocompatibility | Dermal Sensitization(as per ASTM F720-81)Primary Skin Irritation Test(as per 16CFR Part1500) | Not a contact skin sensitizerNot a primary skin irritant |
Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 9.0
The performance test data that support a determination of substantial equivalence are described above.
Lot 2796, 17 ½ Mile, Jalan Kapar, 42200 Klang, Selangor, Malaysia Tel: 603-3291 0516, Fax: 603-3291 0584
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IDEAL QUALITY SDN. BHD. (Company No.404964-P)
Substantial Equivalent Based on Assessment of Clinical Performance Data 10.0
Clinical data are not needed for market cleared examination gloves.
11.0 Conclusion
It can be concluded that the Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored) or, Non Sterile is safe and effective for use and will perform according to the glove performance standards referenced in Section 7 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. SH TAN Quality Assurance Manager IDEAL QUALITY SDN. BHD. Lot 2796, 17 1/2 Miles Jalan Kapar, 42200 Klang, Selangor Darul Ehsan. Malaysia
FEB 2 5 231
Re: K103337
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: February 12, 2011 Received: February 16, 2011
Dear Mr. TAN:
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 Eederal Register.
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Page 2- Mr. TAN
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Susan Bauer
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
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Powder Free Nitrile Patient Examination Gloves, Blue Colored and Device Name: 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
x Over-The-Counter Use (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)
Eby, Wit H. Clavine-Will
ision of Anesthesiology, General Hospit ision Control, Dentrol, Devices i
510(k) Number
§ 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.