(267 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.
Blue Powder Free Nitrile Examination Gloves
This document is a 510(k) premarket notification letter from the FDA regarding "Blue Powder Free Nitrile Examination Gloves." It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the way a performance study for an AI/ML medical device would.
The document establishes that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or has different technological characteristics but does not raise different questions of safety and effectiveness.
For a medical device like examination gloves, the "acceptance criteria" are typically defined by recognized standards related to performance attributes such as barrier integrity (e.g., freedom from holes), tensile strength, and dimensions. The "study" would refer to testing performed by the manufacturer to demonstrate compliance with these standards.
Here's how I can address your request based on the absence of the specific information you're looking for in this type of FDA letter:
Acceptance Criteria and Device Performance Study for "Blue Powder Free Nitrile Examination Gloves"
Based on the provided FDA 510(k) premarket notification letter (K052583), the detailed acceptance criteria and the comprehensive study proving the device meets these criteria, as expected for an AI/ML device, are not explicitly present within this document.
For examination gloves, the "acceptance criteria" are generally derived from established consensus standards (e.g., ASTM, ISO) that define the performance and safety requirements for such devices. The "study" would typically involve laboratory testing. The FDA's substantial equivalence determination for this type of device relies on the manufacturer demonstrating that their device meets these recognized standards, often through bench testing.
However, if we were to infer the types of criteria and studies usually associated with examination gloves, and then report what this document provides, it would look like this:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Hypothetical for Gloves) | Acceptance Criterion (Hypothetical Standard) | Reported Device Performance (Inferred from 510(k)) |
|---|---|---|
| Freedom from holes (water leak test) | AQL 2.5 (e.g., ASTM D5151) | Implied compliance for substantial equivalence |
| Tensile Strength before aging | Standard minimum (e.g., ASTM D412) | Implied compliance for substantial equivalence |
| Tensile Strength after aging | Standard minimum (e.g., ASTM D573) | Implied compliance for substantial equivalence |
| Elongation before aging | Standard minimum (e.g., ASTM D412) | Implied compliance for substantial equivalence |
| Elongation after aging | Standard minimum (e.g., ASTM D573) | Implied compliance for substantial equivalence |
| Powder Residue | Max limit (e.g., ASTM D6124) | Implied compliance for substantial equivalence |
| Dimensions (length, width, thickness) | Standard range (e.g., ASTM D6319) | Implied compliance for substantial equivalence |
| Biocompatibility (e.g., skin irritation) | ISO 10993 series | Implied compliance for substantial equivalence |
Explanation: The FDA letter states the device is "substantially equivalent" to predicate devices. This implies that the manufacturer, Hartalega Sdn. Bhd., submitted data to the FDA demonstrating that their Blue Powder Free Nitrile Examination Gloves meet the performance specifications (e.g., physical properties, barrier integrity, biocompatibility) typically required for patient examination gloves and defined in recognized consensus standards (like ASTM D6319 for Nitrile Examination Gloves) and/or previously cleared predicate devices. The specific test results are not detailed in this public brief.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for performance testing (e.g., for freedom from holes, tensile strength) or the data provenance (e.g., country of origin, retrospective/prospective). For gloves, sampling is typically done according to relevant ASTM or ISO standards from manufacturing lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not relevant or applicable for the regulatory review of physical examination gloves. "Ground truth" in the context of examination gloves refers to objective physical and chemical measurements rather than expert human interpretation.
4. Adjudication method for the test set
Not applicable for objective physical and chemical testing of examination gloves.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For examination gloves, the "ground truth" is established through objective, quantifiable laboratory tests following recognized standards. Examples include:
- Physical measurements: Using calipers for thickness, rulers for length, etc.
- Chemical tests: Using analytical methods for powder residue.
- Mechanical tests: Using tensile testers for strength and elongation.
- Barrier integrity tests: Water leak tests or air inflation tests.
- Biocompatibility tests: In vitro or in vivo tests following ISO 10993 standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
Not applicable. As this is a physical medical device (examination gloves), concepts like "training set" and "ground truth establishment" via expert consensus are not relevant to its regulatory review process for substantial equivalence. The "ground truth" for its performance is derived from standardized laboratory testing.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN I 4 2006
Mr. Kuan Kam Hon Managing Director Hartalega Sdn. Bhd. Lot 9, Jalan Kuang Bulan, Taman Kepong Industrial Estate, 52100 Kuala Lumpur, MALAYSIA
Re: K052583
Trade/Device Name: Blue Powder Free Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 22, 2006 Received: May 25, 2006
Dear Mr. Hon:
-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. Hon
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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), please contact 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,
Sritte Y. Michael Oms.
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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Indication For Use
510(k) Number (if known) : Ko52583
Device Name : Blue Powder Free Nitrile Examination Gloves
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 (Part 21 CFR 801 Subpart D)
OR 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)
Shule M. Murphy 15 6/2/06
I of Anasifiesiology, General Hospital, on Control, Dental Devices
4/2/76 K052583
§ 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.