DuraCLEAN® with LYCRA® Medical Examination Glove is a disposable device made of synthetic LYCRA® polymer that is intended for medical purposes to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants.

Device Description

The subject device is an ambidextrous, powder-free patient examination glove composed of 100% DuPont LYCRA® polymer. It is offered non-sterile, in a range of sizes from Extra Small to Extra Large.

The device meets the requirements of applicable recognized standards, including those specified by ASTM D3578, ASTM D6124, ASTM D5151, and the agency's June, 1999 draft Medical Glove Guidance Mamual.

The device has been demonstrated biocompatible through dermal irritation, dermal sensitization, and cytotoxicity testing in accordance with EN ISO 10993.

AI/ML Overview

The provided text is a 510(k) summary for a medical examination glove, not a device that uses AI or machine learning. Therefore, many of the requested categories for describing an AI/ML device's acceptance criteria and study information are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and how the device meets them based on the provided text for this medical glove.

Acceptance Criteria and Device Performance for DuraCLEAN® with LYCRA® Medical Examination Glove

Acceptance Criteria	Reported Device Performance
Pinhole requirements	Conforms to ASTM D3578
Dimensions	Conforms to ASTM D3578
Physical properties (before and after aging)	Conforms to ASTM D3578
Weight of powder-free residue	Conforms to ASTM D6124
Biocompatibility (dermal irritation)	Demonstrated biocompatible through dermal irritation testing in accordance with EN ISO 10993. In vivo and in vitro testing established the device is biocompatible within the limits of these tests.
Biocompatibility (dermal sensitization)	Demonstrated biocompatible through dermal sensitization testing in accordance with EN ISO 10993. In vivo and in vitro testing established the device is biocompatible within the limits of these tests.
Biocompatibility (cytotoxicity)	Demonstrated biocompatible through cytotoxicity testing in accordance with EN ISO 10993. In vivo and in vitro testing established the device is biocompatible within the limits of these tests.
Conformity to FDA's June, 1999 draft Medical Glove Guidance Manual	The device meets the requirements of the agency's June, 1999 draft Medical Glove Guidance Manual.
Intended Use	Intended for medical purposes to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants. (This is an intended use statement, which is a key part of device acceptance, implying the device performs this function safely and effectively)

Regarding the study that proves the device meets the acceptance criteria (and the AI/ML specific questions):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes for the testing of the glove (e.g., how many gloves were tested for pinholes, physical properties, or biocompatibility). It only states that the device "conforms to" specific ASTM standards and "has been demonstrated biocompatible through" various tests.
- Data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical medical device (glove), not an AI/ML diagnostic or assistive device that requires expert ground truth establishment in the traditional sense. The "ground truth" for a glove is its adherence to mechanical and biological safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a physical medical glove. The testing involves standardized laboratory methods (ASTM, EN ISO 10993) rather than human interpretation requiring 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 as 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 as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is established by adherence to recognized national and international standards for medical gloves: ASTM D3578, ASTM D6124, ASTM D5151 (implied, as D3578 covers many aspects but D5151 is specifically for pinholes), and EN ISO 10993 for biocompatibility. The FDA's June 1999 draft Medical Glove Guidance Manual also serves as a benchmark. These standards define the acceptable performance characteristics.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device; there is no "training set."

Summary of Non-Clinical Tests (from the document):

"In vivo and in vitro testing conducted to assess dermal irritation, dermal sensitization, and cytotoxicity, establish that the subject device is biocompatible within the limits of those test."

Summary of Clinical Tests (from the document):

"(Not applicable)" - This explicitly states that no clinical tests were performed or were deemed necessary for this 510(k) submission, relying instead on non-clinical (laboratory) testing and substantial equivalence to predicate devices.

Summary

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510(k) Summary VII.

K@2205S

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

A. Submitted for

Wilshire Technologies, Inc. 5861 Edison Place Carlsbad, California 92008 Telephone: (760) 929-7200 Contact: Derek Warneke, Vice President of Operations and Technology Date Prepared: June , 2002

B. Device Name

Trade or Proprietary Name: DuraCLEAN®with LYCRA® MedicalExamination Glove
Common or Usual Name:	Patient Examination Glove
Classification Name:	Patient Examination Glove

C. Predicate Devices

The subject device is substantially equivalent, in whole or in part, to predicate gloves manufactured by Maxxim Medical (K991615, K010297 and K011198), Wilshire Technologies (K950033), WRP Asia Pacific (K011482 and K012048), SGMP (K020317), and Tactyl Technologies (K955464).

D. Device Description

The subject device is an ambidextrous, powder-free patient examination glove composed of 100% DuPont LYCRA® polymer. It is offered non-sterile, in a range of sizes from Extra Small to Extra Large.

The device meets the requirements of applicable recognized standards, including those specified by ASTM D3578, ASTM D6124, ASTM D5151, and the agency's June, 1999 draft Medical Glove Guidance Mamual.

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The device has been demonstrated biocompatible through dermal irritation, dermal sensitization, and cytotoxicity testing in accordance with EN ISO 10993.

E. Intended Use

F. Comparison to Predicate Devices

The subject device has the same, or equivalent, indications for use as do other powder-free patient examination gloves cleared for commercial distribution in the U.S.;

The subject device is offered non-sterile, and in a variety of sizes ranging from Extra Small to Extra Extra Large, as are other powder-free patient examination gloves cleared for commercial distribution in the U.S .;

The subject device has the same or equivalent composition as other powderfree examination gloves cleared for commercial distribution in the U.S .;

The subject device conforms to ASTM D3578 in terms of dimensions, physical properties before and after aging, and pinholes, as do other powderfree examination gloves cleared for commercial distribution in the U.S .;

The subject device conforms to ASTM D6124 in terms of weight of powderfree residue, as do other powder-free examination gloves cleared for commercial distribution in the U.S .; and

The subject device has been shown biocompatible through dermal irritation, dermal sensitization and cytotoxicity testing, as have other powder-free examination gloves cleared for commercial distribution in the U.S.

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G. Summary of Non-Clinical Tests

In vivo and in vitro testing conducted to assess dermal irritation, dermal sensitization, and cytotoxicity, establish that the subject device is biocompatible within the limits of those test.

H. Summary of Clinical Tests

(Not applicable)

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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 9 2002

Wilshire Technologies C/O Mr. Steve Reitzler Regulatory Agent 13221 Maricotte Place San Diego, California 92130

Re: K022095

Trade/Device Name: DuraCLEAN® with LYCRA® Powder Free Polyurethane Medical Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 24, 2002 Received: June 27, 2002

Dear Mr. Reitzler:

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.

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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Page 2 - Mr. Reitzler

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 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Ulatowski

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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V. Draft Labeling

Indications for Use A.

510(k) Number (if known):	K 022095
	Powder Free Polyurethane
Device Name:	DuraCLEAN ® with LYCRA ® Medical Examination Glove

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

510(k) Number	K022095
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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.