The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all of the requirements of ASTM D 3577-99, Type 1. The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-99 Rubber Surgical Gloves. The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

AI/ML Overview

The provided text describes a 510(k) summary for medical gloves and does not contain information about a device that uses AI or requires a study involving ground truth, expert consensus, or training sets as outlined in the request.

The device in question, "The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim)," is a medical glove. The acceptance criteria and "study" described are based on compliance with existing ASTM (American Society for Testing and Materials) standards for surgical gloves and FDA hole requirements.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and submission described.

Here's a breakdown of the available information based on your request, highlighting what is not applicable:

1. A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimensions	Meets ASTM D 3577-99	Meets ASTM D 3577-99
Physical Properties	Meets ASTM D 3577-99, Type 1	Meets ASTM D 3577-99, Type 1
Freedom from holes	Meets ASTM D 3577-99	Meets ASTM D 3577-99
	Meets ASTM D 5151-92	Meets ASTM D 5151-92
Protein Label Claim	60 micrograms or less of total water extractable protein per gram. Meets ASTM D 5712-95 Standard Test Method for Analysis of Protein in Natural Rubber and Its Products	This latex glove contains 60 micrograms or less of total water extractable protein per gram. Meets ASTM D 5712-95 Standard Test Method for Analysis of Protein in Natural Rubber and Its Products
Primary Skin Irritation	Passes	Passes
Guinea Pig Sensitization	Passes	Passes

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided text. Compliance with ASTM standards typically involves specified sample sizes for testing, but these are not explicitly detailed here.
Data Provenance: Not specified. The testing is described as "performance test data of the non clinical tests," implying laboratory testing rather than data from a specific country or clinical setting. It's prospective testing against a standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical product (medical glove) and its performance is evaluated against defined physical and chemical standards, not through "ground truth" established by human experts in the context of diagnostic or interpretive tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert reviews. The testing described here is objective and based on established ASTM test methods.

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. This is a medical glove, not an AI-powered diagnostic device. No human reader or AI assistance is involved in its evaluation as described.

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

Not applicable. This is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's performance is adherence to defined physical and chemical properties and biocompatibility tests as specified in ASTM standards.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm; there is no training set.

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

Not applicable. This device is not an AI algorithm; there is no training set or associated ground truth establishment process.

In summary: The provided document describes a medical glove's compliance with established industry standards through non-clinical performance testing. It does not involve AI, human expert evaluation for "ground truth," or clinical studies of the type typically associated with AI-powered diagnostic devices.

Summary

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Jan 3 1 2000

K993857

. .

Attachment 4

510(k) Summary

Summary

Attached

Signature

James R. Chatterton
Typed Name

November 12, 1999
Date

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K99 3857

The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:

[1] Summary
[2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646

Contact:	James R. Chatterton
Telephone:	330-833-2811
Fax:	330-833-6213

November 12, 1999

[3] Trade Name: The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) Common Name: Surgical Gloves Classification Name: Surgeon's Glove
[4] The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all of the requirements of ASTM D 3577-99, Type 1.
[5] The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-99 Rubber Surgical Gloves.
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are sterile disposable [e] devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are summarized with [7] the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standard
Dimensions	Meets ASTM D 3577-99
Physical Properties	Meets ASTM D 3577-99, Type 1
Freedom from holes	Meets ASTM D 3577-99Meets ASTM D 5151-92
Protein Label Claim	This latex glove contains 60 micrograms orless of total water extractable protein pergram.Meets ASTM D 5712-95 Standard TestMethod for Analysis of Protein in NaturalRubber and Its Products
Biocompatability

Primary Skin Irritation in Rabbits Guinea Pig Sensitization

Passes Passes

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Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "KG93857". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with some characters having unique shapes.

The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:

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. വി
It is concluded that The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) [10] are as safe, as effective, and perform as well as the glove performance standards referenced 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/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized human profiles incorporated into the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2000

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

Re : K993857 Trade Name: The Original Perry, Style 42 White Latex Powdered Surqical Gloves With Protein Content Labeling Claim (60 micrograms or less) Regulatory Class: I Product Code: KGO Dated: November 12, 1999 November 15, 1999 Received:

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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Chatterton

the Federal Register. Please note: this response to your premarket notification submission does not affect any premarker nocurright have under sections 531 through 542 of obligation you magne the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as fire ited in your 510 k) premarket notification. The FDA debtired in form of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed production permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpoort 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on Journal Manufacturers Assistance obeation free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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Attachment 2

Indications for Use Statement

510(k) Number (if known)	K993857None, preamendments device
Device Name	The Original Perry Style 42White latex powdered surgical gloves with Protein Content Labeling Claim(60 micrograms or Less)
Indications for Use	The Original Perry Style 42 Surgeon's Glove intended use is to be worn byoperating room personnel to protect a surgical wound from contamination.

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

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(Division Sign-Off) Division of Dental, Infectio and General Hospita 510(k) Number _

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).