This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between the patient and examiner. Powder-free examination gloves are suitable in situations where powder is not desirable.
The Nitrile Powder-Free Medical Examination Glove (blue) is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).

Device Description

Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens.
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens.
Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.

AI/ML Overview

The provided document describes a 510(k) submission for Blue Nitrile Powder-Free Medical Examination Gloves. This submission is for a medical device and not an AI/ML powered device, so several of the requested categories (e.g., MRMC studies, training set details, expert qualifications for AI ground truth) are not applicable.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specification	Acceptance Criteria (Stated as "Predicate")	Proposed Nitrile Powder-Free Medical Examination Glove (blue)	Notes
Watertightness	ASTM standards	Conforms to ASTM standards	The document states "ASTM" for both, implying the proposed device also meets these established ASTM standards.
Safety: Rabbit Irritation	Passes	Passes	The proposed device was tested and passed.
Safety: Guinea Pig Sensitization	Passes	Passes	The proposed device was tested and passed.
Safety: Modified Draze Test	N/A	N/A	This test was "N/A" for both proposed and predicate, indicating it might not be a standard requirement for this type of glove or was not performed.
Performance Standards (General)	ASTM standards	Conforms to ASTM standards	Implies adherence to relevant ASTM physical performance standards for examination gloves.

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

The document does not explicitly state the sample size for physical performance tests (like watertightness or general performance standards). For the safety tests (rabbit irritation and guinea pig sensitization), it indicates that the device "Passes" without providing specific sample sizes.

Test Set Sample Size: Not explicitly stated for performance tests. Not explicitly stated for safety tests, but the results are reported as "Passes" which implies a sufficient sample was used to meet the passing criteria for the relevant tests.
Data Provenance: The studies were conducted by Best Manufacturing Company (USA) for a device intended for the US market. The document does not specify if the safety tests involved retrospective or prospective data collection, but given they are animal studies, they would be prospective.

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

This is not applicable as the device is a physical medical examination glove, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth on a test set. The "ground truth" for this device relies on objective, standardized physical and biocompatibility testing.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in AI/ML studies to establish ground truth or resolve disagreements. Here, the "truth" is determined by objective laboratory measurements and biological reactions (e.g., passing a rabbit irritation test).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are used to evaluate diagnostic performance, often for AI-assisted image analysis. This submission is for a physical medical device (glove) and does not involve human readers or AI assistance in diagnostic tasks.

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

This is not applicable. This submission is for a physical medical examination glove, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective, standardized laboratory measurements and animal biocompatibility test results, as defined by ASTM standards for physical properties and established protocols for safety tests like rabbit irritation and guinea pig sensitization.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML algorithm that requires a training set. The "development" of the glove is based on materials science and manufacturing processes, culminating in testing against established standards.

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

This is not applicable, as there is no training set for this type of medical device.

Summary

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K030075

510(K) SUBMISSION FOR BLUE NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-24 SUMMARY OF SAFETY AND EFFECTIVENESS

A. INFORMATION

SUBMITTER'S Name:

Address:

BEST MANUFACTURING COMPANY

579 Edison Street Menlo, GA 30731 USA

706 862 2302

David C. Young

Examination Glove

Telephone Number:

Contact Person:

Date Summary Prepared: 2002-12-24

1. NAME OF DEVICE Nitrile Powder-Free Medical Trade or Proprietary Name:
  Common or Usual Name

Non-Sterile Nitrile Powder-Free Patient Examination Glove

Classification Name: Patient Examination Glove

Blue Nitrile Powder-Free Medical 3. PREDICATE DEVICE Examination Glove, K992170; and IDENTIFICATION NAME, NUMBER Nitrile Powder-Free Medical Examination Glove (brown), K012166

4. DESCRIPTION OF DEVICE

a. How the device functions: Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens.

b. Scientific concepts that form the basis for the device:
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens.
c. Physical and performance characteristics such as design, materials, and physical properties:
Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.

PAGE 1 OF 3

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510(K) SUBMISSION FOR BLUE NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-240

5. STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASE OR CONDITIONS THAT THE DEVICE WILL ADDRESS

1. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE
- · The proposed device is identical to the predicate device, except for the following:

The formula for the modified device does not contain the cherry flavor and the accelerator/sulfur mixture as found in the predicate K992170. The cherry flavor has been eliminated completely, with no replacement. The accelerator/sulfur mixture has been replaced by WE4-25A ethylene acrylic acid copolymer, as used in predicate K012166.

B. IF SE DECISION BASED ON PERFORMANCE DATA: 1. DISCUSSION OF NON-CLINICAL TESTS

Specification	ProposedNitrile Powder-FreeMedical ExaminationGlove (blue), texturedand non-textured	PredicateBlue Nitrile Powder-FreeMedical ExaminationGlove & Nitrile Powder-FreeMedical Examination Glove(brown)
PerformanceStandards	ASTM	ASTM
Watertightness	ASTM	ASTM
2. DISCUSSION OF CLINICAL TESTS
Specification	Proposed	Predicate
SafetyRabbit Irritation	Passes	Passes
Guinea Pig Sensitization	Passes	Passes
Modified Draze Test	N/A	N/A

PAGE 2 OF 3

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510(K) SUBMISSION FOR BLUE NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-24

DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED ( with specific reference to adverse effects and complications)

See Section M: Biocompatibility Testing.

1. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance =/> PREDICATE PRODUCT
  The Nitrile Powder-Free Medical Examination Glove (blue) has been carefully compared to a legally marketed device in the 510(k). The data summaries indicate that the proposed product meets or exceeds accepted scores for the predicate product in both physical and nonclinical tests and satisfies the requirements for a safe and effective "powder-free" medical glove.

Pursuant to 21 C.F.R. 807.87 (j), I David C. Young, Director, Regulatory Affairs and Quality Assurance, certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Director, Regulatory Affairs and Ouality Assurance, for the Best Manufacturing Company, and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.

David C. Young, Director, Regulatory Affairs & Quality Assurance

2002-12-24
DATE

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.

Public Health Service

MAR 0 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David C. Young Director, Regulatory Affairs & Quality Assurance Best Manufacturing Company 579 Edison Street Menlo, Georgia 30731

Re: K030075

Trade/Device Name: Nitrile Powder-Free Medical Examination Gloves, Blue Textured and Non-textured Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: December 24, 2002 Received: January 8, 2003

Dear Mr. Young:

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 - Mr. Young

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.

Susan Rempen

Susan Runner, DDS, MA Interim 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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510(K) SUBMISSION FOR BLUE NTTRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-24

INDICATIONS FOR USE

Applicant: Best Manufacturing Company 510(k) Number (if known) Device Name: Nitrile Powder-Free Medical Examination Glove (blue) Textured of Nortextured The Nitrile Powder-Free Medical Examination Glove (blue) is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109

Over-The-Counter______________________________________________________________________________________________________________________________________________________________

For a new submission, do NOT fill in the 510(k) number blank.

Olin S. Lim

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

510(k) Number. K030025

PAGE 3 OF 11

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.