These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Duraprene Sterile Synthetic Powder-Free Surgical gloves are formulated using neoprene and are coated with a nitrile coating. These are offered powder-free and sterile.

AI/ML Overview

The provided text describes the safety and effectiveness of "Duraprene Sterile Synthetic Powder-Free Surgical Gloves." This document is a 510(k) summary, which is typically for medical devices, but the information provided pertains to the physical and biological characteristics of surgical gloves rather than an AI/ML powered device. Hence, most of the requested information about AI model performance, ground truth establishment, training sets, and expert adjudication cannot be extracted.

However, I can provide the acceptance criteria and reported device performance for the glove's physical and biological properties.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (as implied by performance)	Reported Device Performance
Intracutaneous Reactivity	No reactivity (implied)	Gloves show no reactivity.
Guinea Pig Maximization	No potential for irritation (implied)	Gloves do not display any potential for irritation.
Barrier Defects	Exceed requirements per 21 CFR §800.20 and ASTM D3577-00, AQL = 1.5	Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-00, AQL = 1.5.
Powder Level	Meet powder level requirements for "Powder Free" designation (below 2 mg/glove)	Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-00. Results generated values below 2 mg of residual powder per glove.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated. The document mentions meeting ASTM standards and CFR regulations, which would specify sample sizes for testing, but the numerical value is not provided in this summary.
Data Provenance: Not explicitly stated. The manufacturer is Allegiance Healthcare Sdn. Bhd. located in Penang, West Malaysia, and Allegiance Healthcare Corporation in McGaw Park, IL, USA. The testing would likely have been conducted in facilities associated with these entities. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document describes the testing of a physical medical device (surgical gloves) for its material properties and biological compatibility, not an AI/ML powered device that would require expert ground truth for interpretation.

4. Adjudication method for the test set:

Not applicable for a physical device test. The tests are based on objective measurements and established standards (e.g., ASTM, CFR).

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 a physical medical device, not an AI/ML powered device.

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

Not applicable as this is a physical medical device. The tests performed are standalone tests of the glove's properties.

7. The type of ground truth used:

The "ground truth" for the tests described are the established scientific and regulatory standards (e.g., ASTM D3577-00 for barrier defects, ASTM D6124-00 for powder level, and biological safety standards for intracutaneous reactivity and sensitization). These are objective measurements against predefined criteria.

8. The sample size for the training set:

Not applicable. There is no AI/ML model being trained.

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

Not applicable. There is no AI/ML model being trained.

Summary

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

DEC 1 7 2001

XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

Allegiance

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES

Manufacturer:	Allegiance Healthcare Sdn. Bhd.Plot 87, Kampung Jawa11900 Bayan LepasPenang, West Malaysia
Regulatory Affairs Contact: Erica Sethi	Allegiance Healthcare Corporation1500 Waukegan Road, MP-WMMcGaw Park, IL 60085
Telephone:	(847) 785-3337
Date Summary Prepared:	9/17/01
Product Trade Name:	Duraprene Sterile Synthetic Powder-Free Surgical Gloves
Common Name:	Surgical Glove
Classification:	Glove, Surgeon's
Predicate Devices:	Duraprene Sterile Synthetic Powder-Free Surgical Gloves
Description:formulated	Duraprene Sterile Synthetic Powder-Free Surgical gloves areusing neoprene and are coated with a nitrile coating.These are offered powder-free and sterile.
Intended Use:	Duraprene Sterile Synthetic Powder-Free Surgical Gloves areintended for use in environments within hospitals and otherhealthcare facilities. The gloves are appropriate for use duringinvasive and non-invasive medical procedures requiring sterility.They are intended to be worn by operating room personnel toprotect a surgical wound from contamination.

ાર

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

KO1 330Z

Page 2

Substantial Equivalence:

Duraprene Sterile Synthetic Powder-Free Surgical Gloves are substantially equivalent to currently marketed Duraprene Sterile Powder-Free Surgical Gloves in that they provide the following characteristics:

same intended use
same sizes, configuration, packaging
both made of neoprene

Summary of Testing:

Test	Result
Intracutaneous Reactivity	Gloves show no reactivity.
Guinea Pig Maximization	Gloves do not display any potential for irritation.
Barrier Defects	Gloves exceed requirements per 21 CFR§800.20 and ASTM D3577-00, AQL = 1.5.
Standard	ASTM D 3577-00
Data/Test Method	Gloves meet powder level requirements for “Powder Free”designation using ASTM Standard D6124-00-Standard test methodfor residual powder on medical gloves. Results generated valuesbelow 2 mg of residual powder per glove.

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

Image /page/2/Picture/1 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 an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2001

C/O Ms. Erica Sethi Regulatory Affairs Manager Allegiance Healthcare Corporation Quality & Regulatory Affairs Division 1500 Waukegan Road, Bldg. WM McGraw Park, Illinois 60085

Re: K013302

Trade/Device Name: Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for use with Chemotherapy Drugs Labeling Claim Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: September 17, 2001 Received: October 3, 2001

Dear Ms. Sethi:

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.

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

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. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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

Allegiance

Allegiance Healdicare Corpοταθο
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500
FAX: 847.785.2460

Page 1 of 1

Applicant: Allegiance Healthcare Corporation

510(k) Number: KO13302

DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH Device Name: TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM.

Indications For Use: These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended 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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

Qhis S. Lin

IDivision Sign-Off) Division of Dental, Infection Control, and General Hospital Device : 90(k) Number _ 6

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).