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.

Device Description

The product is a powder-free, sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane polymer and polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed both as medical examination gloves and dental examination gloves.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (ASTM/ISO Standards)	Reported Device Performance
ASTM D 3578-01a Requirements:
- Freedom from holes	Meets all ASTM D 3578-01a requirements
- Physical properties (except ultimate elongation before aging)	Meets all ASTM D 3578-01a requirements for physical properties, except ultimate elongation before aging. However, it meets the same requirements as the gloves cleared under K011198 (the predicate device). This implies that the predicate device also had this exception, and it was deemed acceptable.
- Physical dimensions	Meets all ASTM D 3578-01a requirements
ISO 10993-Part 10 (Biological Evaluation - Irritation & Sensitization):
- Non-irritating	The gloves have been tested and shown to be non-irritating.
- Non-sensitizing	The gloves have been tested and shown to be non-sensitizing.
ASTM-6124-01 Requirements:
- Labeling as powder-free	Meets requirements of ASTM-6124-01 for labeling as powder free. No powders are utilized in the manufacturer of this glove.
Material Equivalence:
- Same polymer materials as K011198 predicate device	The glove is manufactured using the same polymer materials as described in K011198.
General Safety and Efficacy (relative to predicate):
- No adverse changes to safety and efficacy	There are no adverse changes to the safety and efficacy of the glove products in this submission. The only difference is the sterilization process and packaging change. All requirements for physical properties and dimensions have been met for such uses, based upon comparisons to the predicate devices. The product will be manufactured to the specifications and per documented label claims in K011198.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes used for each test (e.g., freedom from holes, physical properties, irritation, sensitization). It only indicates that the gloves meet the requirements of the standards or have been tested.

The provenance of the data is not specified (e.g., country of origin). Since it's a 510(k) submission to the FDA, it's generally expected that the testing would be conducted in a manner compliant with US regulatory guidelines or internationally recognized standards. The document does not specify if the testing was retrospective or prospective, but given it's for a new clearance, it would typically involve prospective testing of the device being submitted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. For manufacturing and material strength tests like ASTM D 3578-01a or ASTM-6124-01, "experts" in the sense of human interpretation of complex medical images or conditions are typically not involved. These are objective, quantitative tests performed by trained laboratory technicians following standardized protocols. For ISO 10993-Part 10 (biocompatibility), the "ground truth" (i.e., non-irritating/non-sensitizing) is established through standardized animal or in vitro tests, not expert consensus on human data.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective, standardized laboratory tests. There is no indication of subjective assessment or an adjudication process involved in these performance evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This is a submission for a sterile medical examination glove, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a medical device (glove), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the performance claims relies on:

Standardized Test Results: Compliance with established industry standards like ASTM D 3578-01a, ISO 10993-Part 10, and ASTM-6124-01. These standards define the methods and criteria for evaluating factors like freedom from holes, physical properties, biocompatibility (irritation/sensitization), and powder content.
Predicate Device Equivalence: The claim of substantial equivalence to the predicate device (K011198) in terms of materials, physical properties, and safety/efficacy. The predicate device's existing clearance serves as a form of "ground truth" for acceptable performance.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of a physical medical device like a glove. The device's manufacturing processes and material specifications are developed based on engineering principles and existing knowledge, not through machine learning training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device. The "ground truth" for the device's design and manufacturing is established through compliance with recognized standards, validated manufacturing processes, and comparison to existing, cleared predicate devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Maxxim Medical. The logo is in black and white and features the word "MAXXIM" in large, bold letters. Below the word "MAXXIM" is the word "MEDICAL" in smaller letters. The logo is simple and modern.

K021452

510(K) Submission: Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/ Dental Examination Glove

AUG 01 2002

Attachment 4

Summary of Safety and Effectiveness

Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove

Classification:	Class 1
Panel:	Classification by the General Hospital and Personal Use Device
Common Name:	Medical Examination Gloves
	Dental Examination Gloves
Classification Name:	Patient Examination Glove (21 CFR 880.6250)

The purpose of this 510(k) is to obtain an FDA clearance for manufacturing, importing and distributing a sterile, powder-free, polyurethane examination glove. The Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove is substantially equivalent to the SensiCare™ Advantix™ Medical/Dental Examination Glove, originally cleared under K 011198.

The results of the safety, efficacy and performance testing of the Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove are submitted in this 510(k) application and are summarized as follows:

The gloves meet all ASTM D 3578-01a requirements for freedom from holes, physical 1 . properties and physical dimensions, except ultimate elongation before aging. They meet the same requirements as the gloves cleared under K011198.
1. The gloves have been tested and have been shown to be non-irritating and non-sensitizing when tested in accordance with ISO 10993-Part 10.
1. The gloves meet requirements of ASTM-6124-01 for labeling as powder free. No powders are utilized in the manufacturer of this glove.
The glove is manufactured using the same polymer materials as described in K011198. 4.

There are no adverse changes to the safety and efficacy of the glove products in this submission. The only difference in the proposed glove will be the addition of the sterilization process and the change in packaging (single, pair vs. 100 count/box). Each product will be manufactured to the specifications and per documented label claims in K011198.

Signature of Certifier

4/30/02

Date

Julio Gonzalez Typed Name

4750 118th Avenue North · Clearwater, FL 33762

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Julio Gonzalez Director Quality Assurance Maxxim Medical 4750 118" Avenue North Clearwater, Florida 33762

Re: K021452

Trade/Device Name: Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 30, 2002 Received: July 3, 2002

Dear Mr. Gonzalez:

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 vour 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.

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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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

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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510(K) Submission: Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove

Indications for Use

Applicant:	Maxxim Medical, Inc.
510(k) Number (if known):	K021452
Device Name:	Sterile SensiCare® Advantix™ Powder Free PolyurethaneMedical/Dental Examination Glove
Indications for Use:	A patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's hand toprevent contamination between patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

4750 118th Avenue North . Clearwater, FL 33762

Quta Sahn

Page 6

vision Sign-Off)
vision of Dental, Infection Control,
General Hospital Devices
510(k) Number	K021452

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.