These powder-free sterile brown color surgeon's gloves with Nitrile coating are a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Device Description

Sterile Latex Powder-Free Surgical gloves are formulated using natural rubber latex. They are coated with nitrile coating and are offered powder-free and sterile. The gloves are brown in color.

AI/ML Overview

The provided document is a 510(k) summary for "Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating". This document describes the device, its intended use, and substantial equivalence to a predicate device, along with performance testing results.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Primary Skin Irritation	Non-irritating	Gloves are non-irritating.
Guinea Pig Maximization	No potential for sensitization	Gloves do not display any potential for sensitization.
Dimensions	Meet requirements of ASTM D3577	Gloves meet requirements of ASTM D3577.
Physical Characteristics	Meet requirements for rubber surgical gloves per ASTM D3577	Gloves meet requirements for rubber surgical gloves per ASTM D3577.
Freedom from Holes	Meet requirements of 21 CFR 800.20 and ASTM D3577	Gloves meet requirements of 21 CFR 800.20 and ASTM D3577.
Powder Residual	Below 2mg of residual powder per glove (for "Powder-Free")	Results generated values below 2mg of residual powder per glove, meeting "Powder-Free" designation per ASTM D3577 (tested using ASTM D6124).
Protein Content	Less than 50 µg/dm² of total water extractable protein per glove	Yielded the results of less than 50 µg/dm² of total water extractable protein per glove (tested in accordance with ASTM D5712).

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

The document does not explicitly state the specific sample sizes used for each test on the gloves (e.g., how many gloves were tested for freedom from holes or dimensions). The data provenance is generally from testing conducted by or for Cardinal Healthcare 222 LTD. in Thailand, as it's the manufacturer. The tests are "prospective" in the sense that they were conducted for the purpose of demonstrating device performance for this submission, rather than being retrospective analysis of existing data.

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

Not applicable. This device is a surgical glove, and its performance is evaluated through standardized physical, chemical, and biological tests, not through expert interpretation of data like medical imaging. The "ground truth" for these tests are the established standards (e.g., ASTM D3577, 21 CFR 800.20, ASTM D6124, ASTM D5712).

4. Adjudication Method for the Test Set

Not applicable. As noted above, performance is determined by meeting defined physical and biological specifications, not through expert adjudication of ambiguous results.

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

No, an MRMC comparative effectiveness study was not done. Surgical gloves are not typically evaluated using MRMC studies, as they are not diagnostic devices that involve human interpretation of cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical product (surgical glove), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established industry standards and regulatory requirements, such as:

ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
21 CFR 800.20 (Listing of device by type and manufacturer) - for freedom from holes
ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
ASTM D5712 (Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Isoprene Latex)
Biological safety endpoints for skin irritation and sensitization.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set". The term "training set" refers to data used to train an algorithm. For a physical device like a glove, there is no such concept.

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

Not applicable, for the same reasons as point 8.

Summary

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K101811/5001

OCT 1 5 2010 Page of _

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING

Cardinal Healthcare 222 LTD. Manufacturer: 7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng, Rayong, 21140, Thailand

Regulatory Affairs Contact: Tatyana Bogdan, RAC Cardinal Health, Inc. 1430 Waukegan Road McGaw Park, IL 60085

847-887-2325 Telephone:

May 15, 2010 Date Summary Prepared:

Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating Product Trade Name: with Protein Content Label Claim of 50ug/dm- or less

Surgeon's Gloves Common Name:
Surgeon's Gloves Classification Name:

Device Description: Sterile Latex Powder-Free Surgical gloves are formulated using natural rubber latex. They are coated with nitrile coating and are offered powder-free and sterile. The gloves are brown in color.

These powder-free sterile brown color surgeon's gloves with Nitrile Intended Use: coating are a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

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K101811/5001

Predicate Devices:	Coated Sterile Latex Powder-Free Surgical Gloves with Protein-Content-Label-Claim-(50-micrograms-or-less)-previously-cleared ----under 510(k) K992171 (product code KGO);
Substantial Equivalence:	Sterile Latex Powder-Free Surgical Gloves with Nitrile Coatingwith Protein Content Label Claim of 50µg/dm² or less are substantiallyequivalent to the predicate device identified in this 510(k)summary. Substantial equivalence can be established in regard tointended use, physical characteristics, design and product features.Both gloves are made of natural rubber latex using similarmanufacturing process.
Performance Testing:
Test:	Result:
Primary Skin Irritation	Gloves are non-irritating.
Guinea Pig Maximization	Gloves do not display any potential for sensitization.
Dimensions	Gloves meet requirements of ASTM D3577.
Physical Characteristics	Gloves meet requirements for rubber surgical gloves per ASTMD3577.
Freedom from Holes	Gloves meet requirements of 21 CFR 800.20 and ASTM D3577
Powder Residual	Gloves meet powder level requirements for "Powder-Free"designation per ASTM D3577 tested using ASTM standardD6124, Standard test method for residual powder on medicalgloves. Results generated values below 2mg of residual powderper glove.
Protein Content	Gloves have been tested in accordance with ASTM D5712 andyielded the results of less than 50 µg/dm² of total water extractableprotein per glove
Clinical Data:	No clinical data is required.
Conclusion:	The Sterile Latex Powder-Free Surgical Gloves with NitrileCoating and Protein Content Label Claim of 50µg/dm² or less meetthe technological characteristics of ASTM D3577 performancestandard and are substantially equivalent to the predicate deviceidentified in this 510(k) summary.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

0CT 1 5 2010

Re: K101811

Trade/Device Name: Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating With Protein Content Label Claim of 50ug/dm2 or less Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: September 29, 2010 Received: October 1, 2010

Dear Mr. Devine:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Devine

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K101811/5001

Indications for Use

OCT 1 5 2010

510(k) Number (if known): _

Device Name: Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating with Protein Content Label Claim of 50 ug/dm2 or less

Indications for Use: These powder-free sterile brown color surgeon's gloves with Nitrile coating are a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clavius-Wilson

(Division Sign-Off)

Division of Anesthesiology	General Hospital
Infection Control, Devices

510(k) N	K101811
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Cardinal Health, Inc.

Premarket Notification Submission – Traditional 510(k)

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).