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

Latex Surgical Gloves are formulated using Natural Rubber Latex. These are offered powder-free and sterile. Protein Labeling Claim of 50 mcg or less of total water extractable protein

AI/ML Overview

This document describes the safety and effectiveness of Cardinal Health's Polymer Coated Sterile Powder-Free Latex Surgical Gloves (Trade Name: Triflex Select), which received 510(k) clearance (K070647) by demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (from referenced standards)	Reported Device Performance
Primary Skin Irritation	Not explicitly stated, but implied as "non-irritating"	Gloves are non-irritating.
Guinea Pig Maximization (Sensitization)	Not explicitly stated, but implied as "no potential for sensitization"	Gloves do not display any potential for sensitization.
Ultimate Elongation & Tensile Strength	Exceed requirements per ASTM D3577-01 (Standard Specification for Rubber Surgical Gloves)	Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01.
Barrier Defects (Watertightness)	Exceed requirements per 21 CFR §800.20, AQL 2.5 and ASTM D3577-01, AQL = 1.5	Gloves meet AQL of 1.0 (indicating better performance than the required AQLs of 1.5 and 2.5, where lower AQL is better).
Powder Level	Meet "Powder Free" designation using ASTM D6124-01 (residual powder below 2 mg per glove)	Gloves meet powder level requirements for "Powder Free" designation using ASTM D6124-01-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove.
Protein Labeling Claim	50 mcg or less of total water extractable protein	50 mcg or less of total water extractable protein (explicitly stated in the device name and description, implying it met this claim).

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for barrier defects, number of animals for irritation/sensitization). The data provenance is not specified beyond the tests being conducted to meet established ASTM and CFR standards, which are general US regulatory and industry standards. It is implied these are results from device testing, likely conducted retrospectively for the purpose of the 510(k) submission.

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

This information is not applicable to this submission. This device is a surgical glove, and its performance is evaluated against objective, standardized physical, chemical, and biological tests (e.g., ASTM standards, FDA regulations for barrier defects, irritation/sensitization studies). The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified standards and methods, not by expert consensus or interpretation of images/data as would be the case for diagnostic AI devices.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective measurements against pre-defined criteria, not subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for interpretive diagnostic devices where human readers' performance is compared with and without AI assistance. This device is a surgical glove, and its effectiveness is determined by its physical and biological properties.

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

N/A. This device is a physical product (surgical glove), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's "standalone" performance is its intrinsic ability to meet the physical and biological specifications when tested directly.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

Performance Standards: Compliance with established industry standards (e.g., ASTM D3577-01 for physical properties, ASTM D6124-01 for powder level) and FDA regulations (e.g., 21 CFR §800.20 for barrier defects).
Biological Testing Results: Outcomes from standardized primary skin irritation and guinea pig maximization tests.
Chemical Analysis: Measurement of total water extractable protein.

These are objective, measurable criteria, not expert consensus or pathology in the context of medical images or diagnoses.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The performance data presented are from testing carried out on the manufactured product.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for a physical device like a surgical glove.

Summary

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K070647

SUMMARY OF SAFETY AND EFFECTIVENESS As required by §807.92(c)

JUN 2 2 2007

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POLYMER COATED STERILE POWDER-FREE LATEX SURGICAL GLOVES

Regulatory Affairs Contact:	Amy HoydCardinal Health1500 Waukegan RoadMcGaw Park, IL 60085
Telephone:	(847) 578.2325 or 612.998.9341
Fax:	(847) 689.2715
Date Summary Prepared:	2/28/07
Product Trade Name:	Triflex Select
Common Name:	Surgical Glove
Classification:	Glove, Surgeon's
Predicate Device:	Cardinal Health's Coated Sterile Latex Powder-FreeSurgical Gloves (K992171)
Description:	Latex Surgical Gloves are formulated using NaturalRubber Latex. These are offered powder-free andsterile. Protein Labeling Claim of 50 mcg or less oftotal water extractable protein
Intended Use:	Latex Surgical Gloves are intended for use inenvironments within hospitals and other healthcarefacilities. The gloves are appropriate for use duringinvasive and non-invasive medical proceduresrequiring sterility. They are intended to be worn byoperating room personnel to protect a surqical woundfrom contamination.

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SUMMARY OF SAFETY AND EFFECTIVENESS As required by §807.92(c)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POLYMER COATED STERILE POWDER-FREE LATEX SURGICAL GLOVES continued

Substantial Equivalence:	Polymer Coated Sterile Powder-Free Latex Surgical Glovesare substantially equivalent to Coated Sterile Latex Powder-Free Surgical Gloves in that they provide the followingcharacteristics:
	- same intended use

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

Summary of Testing:

Test	Result
Primary Skin Irritation	Gloves are non-irritating.
Guinea Pig Maximization	Gloves do not display any potential for sensitization.
Ultimate Elongation& Tensile Strength	Gloves exceed requirements for rubber surgical glovesper ASTM D3577-01.
Barrier Defects	Gloves exceed requirements per 21 CFR§800.20, AQL 2.5 and ASTM D3577-01, AQL = 1.5.Gloves meet AQL of 1.0
Data/Test Method	Gloves meet powder level requirements for "Powder Free"designation using ASTM Standard D6124-01-Standard testmethod for residual powder on medical gloves. Resultsgenerated values below 2 mg of residual powder per glove.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2007

Cardinal Health, Incorporated C/O Ms. Maryalice Smith Director of Regulatory Affairs and Quality Operations Medical Products Manufacturing 1500 Waukegan Road McGaw Park, Illinois 60085

Re: K070647

Trade/Device Name: Sterile, Latex, Powder-Free Surgeons Glove with Protein Labeling Claim of 50mcg or Less of Total Water Extractable Protein

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 24, 2007 Received: May 25, 2007

Dear Ms. Hoyd:

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.

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Page 2 - Ms. Hoyd

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), please contact the Office 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

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Statement of Indications for Use

510(k) Number: (if known):

K070647

Device Name: Sterile, Latex, Powder-Free Surgeons Glove with Protein Labeling Claim of 50 mcg or less of total water extractable protein

Indications For Use:

Prescription Use (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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shila Page 1 of Murphy, 6

n Sign-Off) rsion of Anesthesiology, General Hospital, clion Control, Dental Devices

3(K) Number: N 0767

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).