The Nugard Black Powder Free Latex Examination Glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a medical device: "Nugard Black Powder Free Latex Examination Glove, Polymer Coated."

This document is a regulatory clearance and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the way one would describe for a diagnostic or algorithmic device. It's a clearance for a Class I medical device (patient examination glove), which typically relies on established performance standards for similar devices rather than novel clinical studies to demonstrate analytical or clinical performance.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to the information provided in this regulatory document.

However, I can extract the relevant information regarding the device's characteristics and the implied "acceptance criteria" for this type of device, which typically involves compliance with recognized standards.

Here's a breakdown based on the provided text, highlighting what is present and what is not:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Material: Natural Rubber Latex	Device is made of natural rubber latex.
Coating: Polymer Coated	Device is Polymer Coated.
Powder: Powder Free	Device is Powder Free.
Protein Content (Water Extractable): Contains 50 Micrograms or Less	Contains 50 Micrograms or less of water extractable protein.
Intended Use: Worn on examiner's hand to prevent contamination between patient and examiner.	(This is the stated Indication for Use, implying the device performs this function).
Sterility: Not specified (implies non-sterile for examination gloves unless otherwise stated, which is typical for examination gloves)	(Not specified in this document, but implied by "examination glove").
Disposable: Disposable device.	Device is a disposable device.
Regulatory Class: Class I, Patient Examination Glove	Device is a Class I Patient Examination Glove.
Regulation Number: 21 CFR 880.6250	Device falls under 21 CFR 880.6250.
Product Code: LYY	Device has Product Code LYY.

Explanation: For Class I devices like examination gloves, the "acceptance criteria" are generally derived from recognized consensus standards (e.g., ASTM standards for medical gloves) that address physical properties, barrier integrity (e.g., freedom from holes), biocompatibility, and protein content for latex gloves. The document confirms that the device meets the description of these characteristics, which serves as the "reported device performance" in this context. The mention of "50 micrograms or less of water extractable protein" is a specific performance claim related to latex allergenicity, common for "low protein" latex gloves.

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided in this document. The FDA 510(k) clearance letter does not detail the specific testing methodologies (like sample size or data provenance) used by the manufacturer to demonstrate compliance with performance standards for physical characteristics, barrier integrity, or protein content. This information would be within the manufacturer's 510(k) submission, not typically in the clearance letter itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided in this document. Ground truth establishment by experts is typically for diagnostic devices where subjective interpretation (e.g., imaging, pathology slides) is involved. For a physical device like a glove, "ground truth" relates to objective measurements against ASTM or ISO standards (e.g., tensile strength, dimensions, freedom from holes, protein assay results). These tests do not typically involve human expert consensus for interpreting results but rather adherence to validated laboratory methods.

4. Adjudication method for the test set

Not Applicable / Not Provided in this document. Adjudication methods (like 2+1, 3+1) are relevant to studies where human readers are making subjective assessments that need to be resolved. This is not pertinent to the evaluation of a physical product like a glove, which is assessed through objective, standardized laboratory tests.

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. An MRMC study is relevant for diagnostic devices, particularly AI-powered ones, to assess the impact of AI on human reader performance. This device is a physical medical glove and does not involve AI or human interpretation in its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical product, not an algorithm. Standalone performance refers to the performance of an AI algorithm independent of human interaction.

7. The type of ground truth used

Implied Ground Truth: For physical characteristics (like dimensions, tensile strength) and chemical properties (like protein content, chemical integrity), the ground truth is established through objective laboratory measurements and validated assays performed according to recognized consensus standards (e.g., ASTM D3577 for latex examination gloves, or specific methods for protein content). The FDA's substantial equivalence determination implies these tests were conducted and met the relevant specifications for predicate devices.

8. The sample size for the training set

Not Applicable / Not Provided in this document. Training sets are used in machine learning for AI algorithms. This device is a physical product.

9. How the ground truth for the training set was established

Not Applicable / Not Provided in this document. As with the training set itself, "ground truth" establishment for a training set is relevant to AI/ML development, which is not applicable here.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2017

Terang Nusa Sdn Bhd Robert Hill Regulatory Director 1 Jalan 8. Pengkalan Chepa 2. Industrial Zone Kota Bharu, 16100 My

Re: K170779

Trade/Device Name: Nugard Black Powder Free Latex Examination Glove, Polymer Coated. Contains 50 Micrograms or less of water extractable protein Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYY Dated: April 21, 2017 Received: April 24, 2017

Dear Robert Hill:

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.

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Lori A. Wiggins -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K170779

Device Name

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14)

Regulation Number and Section

§ 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.