This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.

Device Description

Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria	Reported Device Performance
Dimensions	Meets ASTM D 6319-00ae3	Meets ASTM D 6319-00ae3
Physical Properties	Meets ASTM D 6319-00ae3	Meets ASTM D 6319-00ae3
Freedom from Holes	Meets ASTM D 6319-00ae3 AND Meets ASTM D 5151-99	Meets ASTM D 6319-00ae3 AND Meets ASTM D 5151-99
Powder-Free	Powder content ≤ 2 mg per glove	Powder content ≤ 2 mg per glove
Biocompatibility
Primary Skin Irritation in Rabbits	Passes	Passes
Guinea Pig Sensitization	Passes	Passes

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

The document does not explicitly state the specific sample sizes used for each test (Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Primary Skin Irritation, Guinea Pig Sensitization). However, it implies that the testing was conducted according to the methodologies outlined in the referenced ASTM standards (ASTM D 6319-00ae3 and ASTM D 5151-99), which would specify sample sizes.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective. Given the context of a 510(k) summary for a medical device seeking market clearance in the US, the testing would typically be conducted by the manufacturer or a contracted lab to generate prospective data for regulatory submission.

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

This information is not applicable to the present submission. The device is a medical glove, and its performance is evaluated against engineering and biological standards, not against "ground truth" established by clinical experts interpreting data.

4. Adjudication method for the test set

This information is not applicable for this type of device and testing. The performance is objectively measured against predefined standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves are a physical barrier device, and their performance is assessed through laboratory testing against engineering and biological standards, not through clinical interpretation by human readers.

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

This question is not applicable. The device is a physical glove, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" in this context is the established performance requirements and methodologies detailed in the referenced ASTM standards:

ASTM D 6319-00ae3: Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D 5151-99: Standard Test Method for Detection of Holes in Medical Gloves

For biocompatibility, the "ground truth" is defined by the "Passes" criteria for Primary Skin Irritation in Rabbits and Guinea Pig Sensitization, which are standard biological tests for medical devices.

8. The sample size for the training set

This information is not applicable. The device is a manufactured product, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for this device.

Summary

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K 042817

DEC - 6 2004

510(k) SUMMARY [1]
[2] Ansell Healthcare Products LLC 1635 Industrial Road Dothan, AL 36303

Contact:	Lon D. McIlvain, Vice President Regulatory Affairs
Telephone:	(334) 615-2562
Fax:	(334) 615-2568

October 8, 2004

[3] Trade Name: Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use)
Common Name: Examination Gloves

Classification Name: Glove, Patient Examination, Nitrile

(4) Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00ae3.
Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) [ર] meet all of the current specifications of ASTM D6319-00ae3, Standard Specification for Nitrile Examination Gloves for Medical Application.
Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) (୧) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
[7] Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standard
Dimensions	Meets ASTM D 6319-00ae3
Physical Properties	Meets ASTM D 6319-00ae3
Freedom from Holes	Meets ASTM D 6319-00ae3Meets ASTM D 5151-99
Powder-Free	Powder content ≤ 2 mg per glove
BiocompatibilityPrimary Skin Irritation in RabbitsGuinea Pig Sensitization	PassesPasses

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[8] The performance test data of the non-clinical tests are the same as mentioned immediately above.
Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) [9] process.
It is concluded that Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves [10] (Chemotherapy Use) are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:

ASTM listed standards, FDA hole requirements, and labeling claims for the product.

[11] This summary will include any other information reasonably deemed necessary by the FDA.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2004

Mr. Lon D. McIlvain Vice President Regulatory Affairs Ansell Healthcare Products, LLC 1635 Industrial Road Dothan, Alabama 36303

Re: K042817

Trade/Device Name: Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 8, 2004 Received: October 12, 2004

Dear Mr. Mcllvain:

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. McIlvain

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/dsma/dsmamain.html

Sincerely yours,

Surer Rumser
C. Chia-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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3.0 Indications for Use Statement:

INDICATIONS FOR USE

Applicant:

Ansell Healthcare Products LLC

510(K) Number (if known): _ K 04 28 17 _______________________________________________________________________________________________________________________________________

Device Name:

Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use)

Indications For Use:

Concurrence of CDRH Office of Device Evaluation (ODE)

Suaga Ramo

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042877

Prescription Use Per 21 CFR 801.109 Or

Over-the-Counter Use

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.