NON-STERILE E.P. LATEX EXAMINATION GLOVE

• K Number: K982453
• Device Name: NON-STERILE E.P. LATEX EXAMINATION GLOVE
• Manufacturer: ANSELL PERRY
• Date Cleared: 1998-11-30 ( 138 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

Device Description

Non-Sterile E.P. Latex Examination Gloves, meet all of the requirements of ASTM D 3578. Non-Sterile E.P. Latex Examination Gloves meet all the current specifications for ASTM D 3578 Rubber Examination Gloves. Non-Sterile E.P. Latex Examination Gloves are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner. Non-Sterile E.P. Latex Examination Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.

AI/ML Overview

The acceptance criteria for the Non-Sterile E.P. Latex Examination Gloves and the reported device performance are presented in the following table:

Characteristics	Standard	Reported Device Performance
Dimensions	Meets ASTM D 3578	Meets ASTM D 3578
Physical Properties	Meets ASTM D 3578	Meets ASTM D 3578
Freedom from holes	Meets ASTM D 5151 (FDA hole requirements)	Meets ASTM D 5151
Powder Content	Not more than 2 mg residue by mass (ASTM D 6124)	Powder-Free; Meets described test in Attachment VIII; Not more than 2 mg residue by mass
Biocompatibility (Primary Skin Irritation in Rabbits)	Passes	Passes
Biocompatibility (Guinea Pig Sensitization)	Passes	Passes

Study Details:

1. Sample size used for the test set and data provenance:
   The document states that "The performance test data of the non clinical tests are the same as mentioned immediately above." This implies that the tests were conducted by Ansell Perry Inc. to demonstrate the device's adherence to the specified ASTM standards and biocompatibility requirements. The exact sample sizes for each test are not explicitly provided in this summary. The data provenance is internal to the manufacturer (Ansell Perry Inc.) for non-clinical tests. Clinical data was not deemed necessary for this type of medical device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This device's performance is gauged against established industry standards (ASTM) and regulatory requirements (FDA hole requirements, biocompatibility tests). Ground truth is established by these objective standards and test methodologies, not by expert consensus on individual cases.

3. Adjudication method for the test set:
   Not applicable. The tests are designed to objectively measure specific characteristics against predefined limits set by the standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
   No, an MRMC comparative effectiveness study was not done. The device is a medical glove, and its performance is evaluated based on physical properties and biocompatibility, not on interpretive clinical readings by humans.

5. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, the performance tests described (dimensions, physical properties, freedom from holes, powder content, biocompatibility) are standalone evaluations of the glove's characteristics without a human-in-the-loop component for interpretation. These are material science and biological compatibility tests.

6. The type of ground truth used:
   The ground truth used is based on established, objective, and quantitative standards (ASTM D 3578, ASTM D 5151, ASTM D 6124, and specific biocompatibility test protocols for primary skin irritation and guinea pig sensitization). Compliance with these numerical and qualitative criteria constitutes the ground truth.

7. The sample size for the training set:
   Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context would refer to the development and manufacturing processes to consistently produce gloves meeting the specifications.

8. How the ground truth for the training set was established:
   Not applicable. As noted above, this is not an AI/machine learning device.

Summary

{0}------------------------------------------------

Ansell Perry

K 98 2453

Checklist Section 21.0

ﺔ ﺍﻟﻤﺪﻳﻨﺔ

[1] 510 (k) Summary

• [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646
  Telephone: [phone] Fax: [phone]

James R. Chatterton Contact: Telephone: [phone] Fax: [phone]

July 13, 1998

• Trade Name: Non-Sterile E.P. Latex Examination Gloves [3] Common Name: Examination Gloves Classification Name: Patient Examination Glove
• Non-Sterile E.P. Latex Examination Gloves, meet all of the requirements of ASTM D 3578. [4]
• Non-Sterile E.P. " Latex Examination Gloves meet all the current specifications for ASTM D [ર] 3578 Rubber Examination Gloves.
• Non-Sterile E.P. ® Latex Examination Gloves are non-sterile disposable devices intended for [6] medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
• Non-Sterile E.P. ® Latex Examination Gloves are summarized with the following technological [7] characteristics compared to ASTM or equivalent standards.

Characteristics

Standard

Dimensions

Meets ASTM D 3578

Physical Properties

Meets ASTM D 3578

81

Ansell Perry Inc. • 1875 Harsh Ave. S.E. • Massillon, Ohio 44646 • U.S.A. http://www.ansell.com Telephone: [phone] • Toll Free: 800-321-9752 (USA only) • Fax: [phone]

Non-Sterile E.P. Latex Examination Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: [phone] Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax:

{1}------------------------------------------------

K982453

Non-Sterile E.P. Latex Examination Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: [phone] Fax:

Meets ASTM D 3578

Meets ASTM D 5151

Freedom from holes

Powder-Free Meets described test in Attachment VIII Meets ASTM D 6124 Not more than 2 mg residue by mass.

Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization

Passes Passes

The performance test data of the non clinical tests are the same as mentioned immediately above. [8]

Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. (9)

• [10] It is concluded that Non-Sterile E.P. Latex Examination Gloves 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.

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

{2}------------------------------------------------

Image /page/2/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 an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 30 1998

Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry, Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646

Re: K982453 Non-Sterile E.P.® Latex Examination Glove Trade Name: Requlatory Class: I Product Code: LYY October 15, 1998 Dated: Received: October 19, 1998

Dear Mr. Chatterton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{3}------------------------------------------------

Paqe 2 - Mr. Chatterton

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on comprisines as (advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, & Misbranding by reference to premarket notification (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

Applicant:	Ansell Perry
510(K) Number (if known): *	K982453
Device Name:	LATEX Patient Examination Glove, Powder Free, Beige Color

Indications For Use:

A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Olin S. Lin

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

Over-The-Counter

(Optional Format 1-2-96)

ription Use 'er 21 CFR 801.109

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.