Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.

AI/ML Overview

This report describes the acceptance criteria and study proving the performance of Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim).

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance
Dimensions	Meets ASTM D 3577-00 for Rubber Surgical Gloves, Type 1	Meets ASTM D 3577-00
Physical Properties	Meets ASTM D 3577-00 for Rubber Surgical Gloves, Type 1	Meets ASTM D 3577-00
Freedom from Holes	Meets ASTM D 3577-00 for Rubber Surgical Gloves, Type 1	Meets ASTM D 3577-00 and ASTM D 5151-99
Biocompatibility	Passes Primary Skin Irritation in Rabbits Test	Passes Primary Skin Irritation in Rabbits Test
	Passes Guinea Pig Sensitization Test	Passes Guinea Pig Sensitization Test
Protein Label Claim	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

2. Sample Size and Data Provenance for Test Set

The document does not specify a separate "test set" in the context of clinical trials as clinical data were deemed not needed. The product's performance was evaluated against established ASTM standards through non-clinical testing. The sample sizes for these non-clinical tests (e.g., for dimensions, physical properties, freedom from holes, biocompatibility, and protein content) are not explicitly stated in this summary. The data provenance is non-clinical laboratory testing performed by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not applicable, as the acceptance criteria are based on established ASTM standards and non-clinical laboratory testing, not on expert consensus from clinicians for a specific test set.

4. Adjudication Method for Test Set

Not applicable. The evaluation was based on meeting pre-defined ASTM standards through laboratory testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data are not needed for medical gloves or for most devices cleared by the 510(k) process."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical product (surgical glove), not an algorithm or a device with an AI component requiring standalone algorithm performance evaluation.

7. Type of Ground Truth Used

The "ground truth" for the device's performance relies on:

Established ASTM Standards: For dimensions, physical properties, freedom from holes (ASTM D 3577-00 and ASTM D 5151-99).
Established Biocompatibility Tests: Guinea Pig Sensitization and Primary Skin Irritation in Rabbits.
Established ASTM Standard for Protein Analysis: ASTM D 5712-99 for the protein label claim.

8. Sample Size for Training Set

Not applicable. There is no training set mentioned, as this is a physical medical device evaluated against pre-defined standards, not a machine learning model.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Ansell

K013604

ANSELL HEALTHCARE PRODUCTS INC.
1875 Harsh Ave. S.E. • P.O. Box 550
Marsh Ave. S.E. • P.O. Box 550
330.833.2811 / Bood8-05550 L.S.A.
187.8833.2811 / Boo.321.9752 U.S.A. 330.833.5991 Fax
ansellhealthcare.com

NOV 1 3 2001

Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim)

[1]	510(k) SummaryPage 1 of 2
[2]	Submitter:	Ansell Healthcare Products Inc. Inc.1875 Harsh Avenue SEMassillon, Ohio 44646
	Contact:	James R. Chatterton
	Telephone:	330-833-2811 x297
	Fax:	330-833-6501
	Date ofPreparation:	October 16, 2001
[3]	Trade Name:	Ultralon® Powder Free Latex Surgical Gloves
	Common Name:	Surgical Gloves
	ClassificationName:	Surgeon's Glove
[4]	Legally MarketedDevice to WhichEquivalency IsBeing Claimed:	Ultralon® Powder Free Latex Surgical Gloves, cleared for the market under510(k) K973699, December 16, 1997
[5]	DeviceDescription:	Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) meet allthe current specifications for ASTM D 3577-00, Rubber Surgical Gloves,Type 1.
[6]	Intended Use:	Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) aresterile disposable devices intended to be worn by operating room personnelto protect surgical wounds from contamination.

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K013604

Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6501 Fax: Page 2 of 2

Predicate Device

Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) are [7] Summary of equivalent to the predicate device in that they have the same following Technological Characteristics technological characteristics. Compared to

		Characteristic	Standard
		Dimensions	Meets ASTM D 3577-00
		Physical Properties	Meets ASTM D 3577-00
		Freedom from holes	Meets ASTM D 3577-00
			Meets ASTM D 5151-99
		Biocompatability	Passes Primary Skin Irritation inRabbits Test
			Passes Guinea Pig SensitizationTest
		Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) have theadditional characteristic:
		Protein Label Claim: This latex glovecontains 50 micrograms or less oftotal water extractable protein pergram	Meets ASTM D 5712-99 StandardTest Method for Analysis of Proteinin Natural Rubber and Its Products
[8]	Brief Discussion ofNon-clinical Tests	Non-clinical test data (see [7] above) indicate that the product meets allapplicable ASTM standards, and FDA requirements for biocompatibility andprotein label claim.
[9]	Clinical Tests:	Clinical data are not needed for medical gloves or for most devices clearedby the 510(k) process.
[10]	ConclusionsDrawn from Non-clinical Tests:	It is concluded that the Ultralon® Powder Free Latex Surgical Gloves(Protein Label Claim) are as safe and effective, and perform as well as thepredicate product. They meet ASTM listed standards, and FDArequirements for holes and protein labeling claims.
[11]	Other InformationDeemedNecessary by FDA	This summary will include any other information reasonably deemednecessary by the FDA.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and bottom. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2001

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

Re: K013604

Trade/Device Name: Ultralon ® Powder Free Latex Surgical Gloves with Protein Content Labeling Claim ( 50 Micrograms or Less) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove, Powder-Free Regulatory Class: I Product Code: KGO Dated: October 15, 2001 Received: October 31, 2001

Dear Mr. Chatterton:

We have reviewed your Section 510(k) premarket notification of intent to market the device we mave 10110wed your and have determined the device is substantially equivalent (for the ications 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 mendments, 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 the I cuclar I vou, Drug, the Comment , therefore, market the device, subject to the general approvisions 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 (1 NET), It hay of easy of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of roublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not

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mean that FDA has made a determination that your device complies with other requirements modi that I Drima mass statutes and regulations administered by other Federal agencies. of the Act of ary I oueral states requirements, including, but not limited to: registration 1 ou inust comply with and 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CF reviews) availty systems (QS) regulation (21 CFR Part 820); and if requirents as set form in als quality in 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 310(K) premium not nourication evice 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 II you desire specific ad 1100 100 for in vitro diagnostic devices), please contact the alle additionally 21 CF FC rc at 609116 118. Additionally, for questions on the promotion and Office of Collighance wice, 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 the Act may be occasion 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 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

NOV 1 3 2001

510(k) Number (if known)	K013604
Device Name	Ultralon® Powder Free Surgical Gloves WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Indications for Use	Ultralon® Powder Free Latex Surgical Gloves are to be worn by operating 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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

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

Page 18 of 31

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).