The N-DEX Nitrile Powder-Free Medical Examination Glove 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.

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. The proposed device has no donning powder - this has been replaced by a polyurethane base coating, which is fully cross linked with the nitrile film. The proposed device is labeled "Powder-Free".

AI/ML Overview

The information provided describes the N-DEX Nitrile Powder-Free Medical Examination Glove and its acceptance criteria, particularly focusing on how it compares to a predicate device.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

Specification	Acceptance Criteria (Predicate)	Reported Device Performance (Proposed Device)
Non-Clinical Tests
Performance Standards	ASTM	ASTM
Watertightness	FDA	ASTM
Clinical Tests (Safety)
Rabbit Irritation	(Implied "Passes")	Passes
Guinea Pig Sensitization	(Implied "Passes")	Passes
Modified Draze Test (Human Study)	(Implied "Passes")	Passes

Note: For the clinical safety tests, the predicate device's specific acceptance criteria (e.g., "Passes") are implied as the proposed device is compared against it and also "Passes." The document states the proposed device “meets or exceeds accepted scores for the predicate product.”

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

Sample Size: For the Modified Draze Test (human study), 200 human subjects were used.
Data Provenance: The document does not explicitly state the country of origin for the human subjects, nor does it specify if the study was retrospective or prospective. Given it's a pre-market submission for a new product, it's highly likely to be a prospective study conducted specifically for this submission.

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

This information is not provided in the given text. The Modified Draze Test involves human subjects and observed reactions, but there's no mention of a ground truth established by experts in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable as the described tests are for material safety and performance, not for diagnostic accuracy requiring adjudication of expert interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The study is focused on the device's physical performance, watertightness, and safety (irritation/sensitization) in comparison to a predicate device, not on diagnostic accuracy involving human readers.

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 medical examination glove, not an algorithm or AI system. Its performance is assessed directly through physical and biological tests.

7. The Type of Ground Truth Used:

For the non-clinical tests (Performance Standards, Watertightness), the "ground truth" is defined by industry standards (ASTM) and regulatory requirements (FDA).
For the clinical safety tests (Rabbit Irritation, Guinea Pig Sensitization, Modified Draze Test), the "ground truth" is established by observed biological responses (e.g., absence of irritation or sensitization) in the test subjects, as per the methodologies described in the respective test standards.

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical product (medical examination glove) and does not involve a "training set" in the context of machine learning or algorithms.

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

This question is not applicable for the same reason as #8.

Summary

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K99217$\phi$

SEP 7 1999

510(K) SUBMISSION FOR N-DEX NITRILE POWDER-FREE MEDICAL EXAMINATION GLO SUBMISSION DATE: 1999-06-16

SUMMARY OF SAFETY AND EFFECTIVENESS

A. INFORMATION 1. SUBMITTER'S Name: BEST MANUFACTURING COMPANY Address: 579 Edison Street Menlo, GA 30731 USA Telephone Number: 706 862 2302 Contact Person: David C. Young Date Summary Prepared: 1999-06-16 2. NAME OF DEVICE Trade or Proprietary Name: N-DEX Nitrile Powder-Free Medical Examination Glove Common or Usual Name Non-Sterile Nitrile Powder-Free Patient Examination Glove Classification Name: Patient Examination Glove 3. PREDICATE DEVICE N-DEX, K902696 IDENTIFICATION NAME. NUMBER 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 N-DEX NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 1999-06-16

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

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.

6. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE

· The proposed device is identical to the predicate device, except for the following:

The proposed device has no donning powder - this has been replaced by a polyurethane base coating, which is fully cross linked with the nitrile film.

The proposed device is labeled "Powder-Free".

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

Specification	ProposedN-DEX Nitrile Powder-Free Medical ExaminationGlove	PredicateN-DEX
Performance Standards	ASTM	ASTM
Watertightness	ASTM	FDA
2. DISCUSSION OF CLINICAL TESTS
SpecificationSafety	Proposed	Predicate
Rabbit Irritation	Passes	N/A
Guinea Pig Sensitization	Passes	N/A
Modified Draze Test(Human Study)	Passes	N/A

DESCRIPTION OF SUBJECTS

For the Modified Draze Test, 200 human subjects were used. The criteria for inclusion in the study was as discussed in the study, pages 6 and 7, paragraphs 3.11 and 3.12 (see Section M: Human and Animal Testing). PAGE 2 OF 3

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510(K) SUBMISSION FOR N-DEX NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 1999-06-16

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

See Section M: Human and Animal Testing, page 4 "SUMMARY", of the Modified Draze Test.

1. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance =/> PREDICATE PRODUCT
  The N-DEX Nitrile Powder-Free Medical Examination Glove 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 nonclinical tests and satisfies the requirements for a safe and effective "powder-free" medical glove.

Pursuant to 21 C.F.R. 807.87 (i), 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 Quality 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 (l

1999-06-16

David C. Young, Director, Rep Jalatory Affairs & Quality Assurance DATE

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling a central graphic. The graphic features a stylized representation of a human figure, composed of three overlapping profiles facing to the right, suggesting a sense of community and support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP | 7 | 1999

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

K992170 Re : N-DEX Blue Powder-Free Nitrile Medical Trade Name: Examination Glove Requlatory Class: I Product Code: LZA Dated: June 16, 1999 Received: June 28, 1999

Dear Mr. Young:

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 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ರ್ಥ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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

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Page 2 - Mr. Young

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Tim Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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K992170

S IO(K) SUBMISSION FOR N-DEX NTTRILE POWDER-FREE MEDICAL EXAMINATION GALO SUBMISSION DATE: 1999-06-16

INDICATIONS FOR USE

Best Manufacturing Company Applicant: 510(k) Number (if known) 510(K) Name: N-DEX Nitrile Powder-Free Medical Examination Glove

The N-DEX Nitrile Powder-Free Medical Examination Glove is a disposable The N-DEA Nittle Fower Tree Inc. I receins 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 OR

Over-The-Counter

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

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ums. 5. Lin

(Division Sign-Off)
Division

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Division of Dental, Infection Control,
and General Hospital, Devis and General Hospital 510(k) Number

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.