These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.

Device Description

Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less)

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimensions	Meets ASTM D 3577	Meets ASTM D 3577
Physical Properties	Meets ASTM D 3577, Type 2	Meets ASTM D 3577, Type 2
Freedom from Holes	Meets ASTM D 3577	Meets ASTM D 3577
	Meets ASTM D 5151	Meets ASTM D 5151
Powder-Free	Meets ASTM D 6124	Meets ASTM D 6124
	Powder content ≤ 2 mg per glove	Powder content ≤ 2 mg per glove
Biocompatibility	Non-Toxic at 24 hours	Non-Toxic at 24 hours
FHSA Skin Irritation	Passes	Passes
ISO Maximization Sensitization	Passes	Passes
Cytotoxicity	Passes	Passes
Protein Label Claim	Contains 50 micrograms or less of total water extractable protein per gram	Contains 50 micrograms or less of total water extractable protein per gram
Protein Analysis Method	Meets ASTM D 5712-99	Meets ASTM D 5712-99

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

The provided text does not explicitly state the sample size used for the non-clinical tests. It refers to these as "performance test data of the non-clinical tests."

The data provenance is not specified (e.g., country of origin). Since it refers to widely used ASTM and ISO standards, it's likely that the tests were conducted in a laboratory setting adhering to these international standards. The study appears to be retrospective in the sense that the data being presented are from tests already performed to demonstrate compliance with existing standards.

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

The document does not mention the use of experts in the context of establishing ground truth for the device's performance against the listed standards. The acceptance criteria are based on established industry standards (ASTM, ISO), which inherently represent a consensus of expert knowledge in glove manufacturing and medical device safety. The "ground truth" for these tests is the quantitative measurement or qualitative observation against the predefined parameters of these standards.

4. Adjudication Method for the Test Set:

There is no explicit adjudication method described. Compliance with the standards would typically involve laboratory analysis and direct measurement against the specified thresholds. Discrepancies, if any, would be resolved by re-testing or investigation, but no formal expert adjudication process (like 2+1, 3+1) is mentioned or typically required for this type of product testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. The device is a sterile latex surgical glove. MRMC studies are typically used for diagnostic or screening devices that involve human interpretation of images or other data. This product does not involve such a human-in-the-loop diagnostic process.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Yes, in essence. The performance tests described (Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Biocompatibility components, Protein Label Claim) are all standalone performance evaluations of the glove itself. These tests are conducted without any human-in-the-loop assistance in decision-making related to the device's function as a diagnostic or analytical tool. The human element would be in conducting the tests and recording results, but not in interpreting the "output" of the device for a medical diagnosis.

7. The Type of Ground Truth Used:

The ground truth used is primarily established industry standards and regulatory requirements. This includes:

ASTM (American Society for Testing and Materials) standards: D 3577 (Dimensions, Physical Properties, Freedom from Holes), D 5151 (Freedom from Holes), D 6124 (Powder-Free), D 5712-99 (Protein Analysis).
ISO (International Organization for Standardization) standards: for Biocompatibility (Maximization Sensitization Study).
FHSA (Federal Hazardous Substances Act) standards: for Biocompatibility (Skin Irritation Study).
FDA hole requirements: mentioned as a general compliance point.

8. The Sample Size for the Training Set:

This question is not applicable to this type of device. The device is a physical medical product (surgical glove), not an AI/ML algorithm or a device that requires a "training set" in the context of machine learning. The term "training set" is relevant for AI models, not for characterizing a physical product like a glove.

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

This question is not applicable for the same reason as point 8.

Summary

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AUG 1 7 2005

051793

Page 1 of 2

510(k) SUMMARY [1]

Ansell Healthcare Products LLC [2] 1635 Industrial Road Dothan, AL 36303
Lon D. McIlvain, Vice President Regulatory Affairs Contact: (334) 615-2562 Telephone: (334) 615-2568 Fax:

June 29, 2005

[3] Trade Name:	Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less)
-----------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------

Surgical Gloves Common Name:

Classification Name: Surgeon's Glove

Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft (4) Encore Sterne Forwards And Protein Labeling Claim (50 micrograms or less) Couting (Containents of ASTM D 3577, Type 2.
Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft ાં રો Enoore Sterne in the Glycerine) And Protein Labeling Claim (50 micrograms or less) Southing (Sthe current specifications of ASTM D 3577, Type 2.
Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft (୧) Eneore Sterne ining Glycerine) And Protein Labeling Claim (50 micrograms or less) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.
Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft [7] Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) arc summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standard
Dimensions	Meets ASTM D 3577
Physical Properties	Meets ASTM D 3577, Type 2
Freedom from Holes	Meets ASTM D 3577Meets ASTM D 5151
Powder-Free	Meets ASTM D 6124Powder content ≤ 2 mg per glove

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Biocompatibility:

FHSA Skin Irritation Study ISO Maximization Sensitization Study Cytotoxicity Study using the End-Point Titration Method

K051793
page2of2

Non-Toxic at 24 hours

Passes

Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Encore Sterne Fowder Trowder Trotein Labeling Claim (50 micrograms or less) have the additional characteristic:

Protein Label Claim: This latex glove
contains 50 micrograms or less of
total water extractable protein per
gram

Meets ASTM D 5712-99 Standard Test Method for Analysis of Protein in Natural Rubber and Its Products

The performance test data of the non-clinical tests are the same as mentioned [8] immediately above.
Clinical data is not needed for medical gloves or for most devices cleared by the ીતે તે જે તે તે જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા 510(k) process.
It is concluded that Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove [10] With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) 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 [11] FDA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 2005

Ansell Healthcare Products, LLC C/O Ms. Cynthia A. Ingram Regulatory Affairs Manager, Americas 1635 Industrial Road Dothan, Alabama 36303

Re: K051793

Trade/Device Name: Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove with Hydrasoft coating (containing Glycerine) and Protein Labeling Claim (50 micrograms or less) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's glove Regulatory Class: I Product Code: KGO Dated: June 30, 2005 Received: July 1, 2005

Dear Ms. Ingram:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the energe, 1976, the enactment date of the Medical Device Amendments, or to conniner or prior to ria) 20, since) in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act 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 r ou mayy areres, while 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 - Ms. Ingram

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dr mination that your device complies with other requirements of the Act that I Dri Hab made a and regulations administered by other Federal agencies. You must or uny I vith 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 CI K rut 6077, aboning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly in and quians of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of the provide as are in arketing your device as described in your Section 510(k) I mis lotter will and my Jorne FDA finding of substantial equivalence of your device to a legally prematicated predicated." - 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 If you active 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 other general 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/industry/support/index.html.

Sincerely yours,

Ching Liu, 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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Indications for Use Statement: 3.0

INDICATIONS FOR USE

510(K) Number (if known): K051793

Device Name:

Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove with Hydrasoft coating (containing Glycerine) and Protein Labeling Claim (50 micrograms or less)

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Shelli A. Murphy, ko 8/16/05

(Division Sign-C Division of Anesthesi Intection Control, Dental

510(k) Number. K051243 -12-

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).