(39 days)
The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powdered Examination Gloves (White)
The provided document describes an FDA 510(k) clearance for "Nitrile Powdered Examination Gloves (White)" (K050215). This is a manual device, not an AI or software-based device. Therefore, the questions regarding acceptance criteria and studies related to AI performance, such as sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
The clearance is based on substantial equivalence to legally marketed predicate devices, meaning the device performs as intended for its indicated use.
1. Table of Acceptance Criteria and Reported Device Performance:
For manual examination gloves, typical acceptance criteria relate to physical properties and barrier integrity to ensure they meet performance standards for their intended use (preventing contamination). These criteria are generally established by international standards (e.g., ASTM, EN standards). The FDA 510(k) summary (which is not fully provided here, only the clearance letter) would reference these standards and the device's compliance.
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Acceptance Criteria (General for Examination Gloves):
- Freedom from holes: AQL (Acceptable Quality Level) of 2.5 or 4.0 for water leak test.
- Tensile Strength & Elongation: Must meet minimum requirements defined by standards (e.g., ASTM D412, EN 455-2).
- Dimensions (Length, Width, Thickness): Must be within specified ranges defined by standards.
- Powder Content (if powdered): Usually a maximum limit (e.g., 2 mg/glove).
- Biocompatibility: Must be non-toxic and non-irritating (e.g., ISO 10993 tests for cytotoxicity, sensitization, irritation).
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Reported Device Performance:
The clearance letter states the device is "substantially equivalent" to legally marketed predicate devices for its indicated use: "a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This implies the device met the relevant performance standards for examination gloves, demonstrating its safety and effectiveness. Specific numerical performance data is not typically found in the FDA clearance letter itself but would be detailed in the 510(k) submission summary.
2. Sample size used for the test set and the data provenance:
- Not applicable for this type of device. Testing for examination gloves generally involves destructive and non-destructive testing on samples taken from production lots, following statistical sampling plans outlined in relevant standards (e.g., ISO 2859-1 for AQL sampling). This is not "data" in the context of clinical studies for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for this device is established by objective physical and chemical testing against defined standards, not by expert interpretation.
4. Adjudication method for the test set:
- Not applicable. Testing involves objective measurements, not subjective 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:
- Not applicable. This is a manual device, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a manual device, not an algorithm.
7. The type of ground truth used:
- For examination gloves, the "ground truth" is adherence to established international and national performance standards (e.g., ASTM D6319, EN 455 series) for physical properties (tensile strength, elongation, dimensions), barrier integrity (water leak test), and biocompatibility.
8. The sample size for the training set:
- Not applicable. This is a manual device, not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is a manual device, not an AI device.
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MAR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kuan Eu Jin Quality Management Representative Hartalega Sdn Bhd Lot 9, Jalan Kuang Bulan, Taman Kepong Industrial Estate, 52100 Kuala Lumpur, MALAYSIA
Re: K050215
Trade/Device Name: Nitrile Powdered Examination Gloves (White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: II Product Code: LZA Dated: February 23, 2005 Received: March 2, 2005
Dear Mr. Jin:
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 approvial applisions of the Act. The general controls provisions of the Act include controls 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. Jin
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 moan that + = = } } Federal statutes and regulations administered by other Federal agencies. or the For of all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 CF CF rth 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) Print reter notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), rr you acuntact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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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Indications for Use
510(k) Number (if known) : K050215
Device Name : Nitrile Powdered Examination Cloves (White)
Indications For Use :
The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Per 21 CFR 801 Subpart D) ()।ર
Over-The-Counter Use X (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)
Shade H. Murphy, D
iston Gign-Off) ulsion of Anesthesiology General Hospital, In astion Control, Dental Devices
(k) Number: K6502is
§ 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.