These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination 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.

Device Description

Powder-Free Sterile Synthetic Surgical gloves are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.

AI/ML Overview

The provided document describes the safety and effectiveness of "Esteem Sterile Polyisoprene Surgical gloves," which are powder-free, sterile, synthetic surgical gloves. The study summarized in the document is a series of tests to demonstrate substantial equivalence to a predicate device, "Duraprene Powder-Free Sterile Synthetic Surgical Gloves." This is a premarket notification (510(k)) submission to the FDA.

Here's the breakdown of the requested information:

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

Test	Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance
Intracutaneous Reactivity	No irritation shown by predicate device	Gloves show no irritation.
Guinea Pig Maximization	No potential for sensitization shown by predicate device	Gloves do not display any potential for sensitization.
Ultimate Elongation & Tensile Strength	Meet requirements per ASTM D3577-00 for rubber surgical gloves	Gloves exceed requirements for rubber surgical gloves per ASTM D3577-00.
Barrier Defects (AQL)	Meet 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 Free" designation, i.e., below 2 mg of residual powder per glove, using ASTM Standard D6124-97	Results generated values below 2 mg of residual powder per glove.

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

The document does not specify the sample sizes used for any of the tests. It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission for a medical device (surgical gloves), these tests would typically be laboratory-based and conducted prospectively to evaluate the physical and biological properties of the manufactured gloves.

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)

This is not a diagnostic device or a device where "ground truth" is established by human expert interpretation in the way it is for imaging or clinical decision support AI. The "ground truth" for surgical gloves is defined by recognized industry standards (ASTM, CFR) and biological safety assessments. Therefore, the concept of "experts establishing ground truth for the test set" with specific qualifications (like a radiologist) is not applicable here. The tests themselves are the "truth" against established scientific and regulatory benchmarks.

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

Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation or clinical endpoints where there might be disagreement. This is not relevant for the objective laboratory and biological tests conducted for surgical gloves. These tests yield quantitative results that are then compared against predefined criteria.

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

An MRMC comparative effectiveness study is not applicable as this is a device (surgical glove), not an AI algorithm for interpretation or diagnosis.

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

This question is not applicable as the device is a physical product (surgical glove), not a standalone AI algorithm.

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

The "ground truth" for the device's performance is established by:

Industry Standards: ASTM D3577-00, ASTM Standard D6124-97
Regulatory Requirements: 21 CFR §800.20
Biological Safety Assessments: Intracutaneous Reactivity and Guinea Pig Maximization tests, which rely on established methods for assessing biocompatibility.

8. The sample size for the training set

This question is not applicable as this is a physical device, not an AI model that requires a training set.

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

This question is not applicable as this is a physical device, not an AI model that requires a training set.

Summary

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

AUG 1 4 2001

XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

KO/1721

Allegiance

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

Regulatory Affairs Contact: Erica Sethi	Allegiance Healthcare Corporation1500 Waukegan Road, MP-WMMcGaw Park, IL 60085
Telephone:	(847) 785-3337
Date Summary Prepared:	5/25/01
Product Trade Name:	Esteem Sterile Polyisoprene Surgical gloves
Common Name:	Surgical Glove
Classification:	Glove, Surgeon's
Predicate Devices:	Duraprene Powder-Free Sterile Synthetic Surgical Gloves
Description:	Powder-Free Sterile Synthetic Surgical gloves are formulated usingSynthetic Rubber Latex. These are offered powder-free and sterile.
Intended Use:	Powder-Free Sterile Synthetic 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.

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

Koi ICI

Page 2

Substantial Equivalence:

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

same intended use

Gloves show no irritation.

same sizes, product features, packaging
both made of Synthetic Rubber Latex using similar manufacturing process

Summary of Testing:

Test

Result

Intracutaneous Reactivity

Guinea Pig Maximization

Ultimate Elongation & Tensile Strength

Barrier Defects

Data/Test Method

Gloves do not display any potential for sensitization.

Gloves exceed requirements for rubber surgical gloves per ASTM D3577-00.

Gloves exceed requirements per 21 CFR $800.20 and ASTM D3577-00, AQL = 1.5.

Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text is centered and appears to be extracted from a document or sign.

Image /page/2/Picture/10 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2001

Ms. Erica Sethi Manager of Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road 60085 McGaw Park, Illinois

K011721 Re : Powder-Free Sterile Synthetic Trade/Device Name: Polyisoprene Surgical Gloves Regulation Number: 878.4460 Regulatory Class: I Product Code: KGO Dated: May 4, 2001 Received: June 4, 2001

Dear Ms. Sethi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marree is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate abe beaut in on erstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che chat have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the roading the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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

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

Page 2 - Ms. Sethi

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 requlation (21 CFR Part 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" (21CFR 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,

Patricia Cuesnitoffor

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}------------------------------------------------

fillegarra

Allegiance Healthcare Corporation 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:	K011721
Device Name:	Powder-Free Sterile Synthetic Surgical Gloves (POLYISOPRENE)
Indications For Use:	These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination 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.

(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 _

Qiu Si Lin

(Division Sign-Off) (Division of Dental, Infection Control,
Division of Dental, Infection Control, Division of Dentall Device 510(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).