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. These latex gloves contain 50 micrograms or less of water extractable protein per gram.

Device Description

Protegrity Sterile Latex/Nitrile Surgical Gloves with brown colorant, proprietary coating (containg Chitosan, Provitamin B, Gluconolactone and Glycerol) and protein labeling claim (50 MICROGRAMS or Less)

AI/ML Overview

The provided document describes the safety and effectiveness summary for Protegrity Sterile Latex/Nitrile Surgical Gloves. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Primary Skin Irritation	Devices should be non-irritating.	Gloves are non-irritating.
Guinea Pig Maximization	Devices should not display potential for sensitization.	Gloves do not display any potential for sensitization.
Ultimate Elongation & Tensile Strength	Exceed requirements for rubber surgical gloves per ASTM D3577-01a2.	Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01a2.
Barrier Defects	Exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2.	Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2.
Powder Level	Meet powder level requirements for "Powder Free" designation.	Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01. Results generated values below 2 mg of residual powder per glove.
Water extractable protein per gram	Less than 50 micrograms.	These latex gloves contain 50 micrograms or less of water extractable protein per gram. (This is mentioned in the description and indications for use, implying it is a key characteristic/criterion).

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 guinea pigs for sensitization). The provenance of the data (country of origin, retrospective or prospective) is also not specified.

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

This information is typically not applicable to studies for surgical gloves, as the "ground truth" is established through standardized laboratory and biological tests rather than expert interpretation of medical images or patient data. The tests are defined by specific ASTM and CFR standards.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements against established technical standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This is a medical device for physical protection, not an AI-based diagnostic or assistive technology.

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

Not applicable. This is a medical device for physical protection, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established industry standards and regulatory requirements. These include:

ASTM International Standards: Specifically ASTM D3577-01a2 for ultimate elongation & tensile strength, and barrier defects; and ASTM D6124-01 for residual powder.
Code of Federal Regulations (CFR): Specifically 21 CFR §800.20 for barrier defects.
Biological Compatibility Standards: Implied for Primary Skin Irritation and Guinea Pig Maximization tests, demonstrating biocompatibility.
Chemical/Analytical Standards: For water extractable protein content.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense. The "training" for the manufacturing process would be part of Good Manufacturing Practices (GMP) and quality control, but not a data-driven training set for an algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for an algorithm. For a physical medical device like surgical gloves, the "ground truth" or acceptable performance is established through adherence to the aforementioned ASTM and CFR standards during the development and manufacturing process.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K033905'. The characters are written in a clear, sans-serif font, and they appear to be part of a code or identification number. The image is simple and focuses solely on the alphanumeric sequence.

APR 2 7 2004

XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PROTEGRITY STERILE LATEXNITRILE SURGICAL GLOVES WITH BROWN COLORANT, COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) AND PROTEIN LABELING CLAIM

Regulatory Affairs Contact:	Erica SethiCardinal Health1500 Waukegan Road, MP-WMMcGaw Park, IL 60085
Telephone:	(847) 785-3337
Date Summary Prepared:	4/26/04
Product Trade Name:	Undetermined
Common Name:	Surgical Glove
Classification:	Glove, Surgeon's
Predicate Devices:	Protegrity Sterile Latex Surgical Gloves
Description:	Protegrity Sterile Latex/Nitrile Surgical Gloves withbrown colorant and coating are formulated usingNatural Rubber Latex and Nitrile. These are offeredpowder-free and sterile. These latex gloves contain 50micrograms or less of water extractable protein pergram.
Intended Use:	Protegrity Sterile Latex/Nitrile Surgical Gloves withbrown colorant and coating are intended for use inenvironments within hospitals and other healthcarefacilities. The gloves are appropriate for use duringinvasive and non-invasive medical procedures requiringsterility. They are intended to be worn by operatingroom personnel to protect a surgical wound fromcontamination.

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K033905

: 上一篇:

Substantial Equivalence: Protegrity Sterile Latex/Nitrile Surgical Gloves with brown colorant and coating are substantially equivalent to Protegrity Sterile Latex Surgical Gloves in that they provide the following ・ characteristics:

same intended use
same sizes, product features, packaging
both made of Natural Rubber Latex and Nitrile using similar manufacturing process

Summary of Testing:

- - - - and the contraction of the comments of the control of : :

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 D3577-01a2.
Barrier Defects	Gloves exceed requirements per 21 CFR§800.20 and ASTM D3577-01a2.
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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Cardinal Health Ms. Erica Sethi Manager, Regulatory Affairs Medical Product and Scrvices 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085

Re: K033905

Trade/Device Name: Protegrity Sterile Latex/Nitrile Surgical Gloves with Proprietary Coating (Containing Chitosan, Provitamin B, Gluconolactone and Glycerol) with Protein Content Labeling Claim (50 Micrograms or Less) & Brown Coloring Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 4, 2004 Received: March 5, 2004

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.

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Page 2 - Ms. Sethi

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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

Enclosure

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মুম CardinalHealth

1500 Waukagan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847,785.2460

		Page 1 of 1
Applicant:	Cardinal Health
510(k) Number:	K033905
Device Name:	Undetermined
Device description:	Protegrity Sterile Latex/Nitrile Surgical Gloves with brown colorant,proprietary coating (containg Chitosan, Provitamin B, Gluconolactoneand Glycerol) and protein labeling claim (50 MICROGRAMS or Less)
Indications For Use:	These gloves are intended to be worn by operating room personnel toprotect a surgical wound from contamination in environments withinhospitals and other healthcare facilities. The gloves are appropriate foruse during invasive as well as non-invasive medical proceduresrequiring sterility. These latex gloves contain 50 micrograms or less ofwater extractable protein per gram.
Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use X(21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kevin Mulvey

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices

510(k) Number: K033905

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).