NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE

• K Number: K982131
• Device Name: NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
• Manufacturer: ANSELL EDMONT INDUSTRIAL, INC.
• Date Cleared: 1998-10-29 ( 134 days)
• Product Code: LZA
• Regulation Number: 880.6250

Intended Use

A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

Device Description

Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.

Therapeutic

No
The device, examination gloves, is intended to prevent contamination and for handling chemotherapy drugs, which are protective rather than therapeutic actions.

Diagnostic

No

Explanation: The device description states it is a disposable device worn on the examiner's hand to prevent contamination and for handling chemotherapy drugs. This function is protective, not diagnostic.

SaMD (Software as a Medical Device)

No

The device is described as a "disposable device" and "worn on the examiners hand," indicating it is a physical product (gloves) and not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The primary intended use is to prevent contamination between patient and examiner and for handling chemotherapy drugs. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
• Device Description: The description reinforces the barrier function of the gloves.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological specimens.
  • Detecting or measuring substances in specimens.
  • Providing information for diagnosis, monitoring, or screening.
  • Using reagents or assays.

The device is a medical glove, which is a Class I or Class II medical device depending on its specific properties and intended use, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

Product codes

LZA

Device Description

Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance test data of the non clinical tests are the same as mentioned immediately above. Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. It is concluded that Nitra-Touch™ examination gloves are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet: ASTM listed standards, FDA hole requirements, and labeling claims for the product.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

• Original Ultimate Elongation 500% minimum
• Aged Ultimate Elongation 400% minimum
• Not more than 2 mg residue by mass.
• Tensile Strength 60% higher than vinyl (synthetic) examination gloves Vinyl = 10.5 Nitra-Touch™ = 17.1 (MPa)
• Puncture resistance of Nitra-TouchTM is eight (8) times greater than vinyl and nearly twice that of competitive nitrile gloves (lbf/in) Nitra-Touch™ = 1625 Blue Nitrile = 929 Vinyl (Synthetic) = 184
• Permeation Rate = 480 (minutes) (for glutaraldehyde)
• Biocompatibility: Primary Skin Irritation in Rabbits - Passes, Guinea Pig Sensitization - Passes

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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K982131

Ansell Edmont Industrial Inc.

Costincton OH 43812

Technology Center Telephone: [phone] Technology Center Fax: [phone]

i

Nitra-Touch™ Ansell Edmont Industrial, Inc. 1300 Walnut Street Coshocton, Ohio 43812 Telephone: [phone] Fax: [phone]

Checklist Section 21.0

OCT 2 9 1998

• 510 (k) Summary [1]
• [2] Ansell Edmont Industrial, Inc. 1300 Walnut Street Coshocton, Ohio 43812

Telephone: [phone] Fax:

Contact: Mike W. Hagans Telephone: [phone] Fax:

June 12, 1998

[3]	Trade Name:	Nitra-Touch™
	Common Name:	Exam Gloves
	Classification Name:	Patient Examination Glove

• Nitra-Touch™ examination gloves, meet all of the requirements of ASTM D 3578 with [4] the following variation.
• Nitra-Touch™ examination gloves meet all the current specifications for ASTM D 3578 [ર] Rubber Examination Gloves except for the ultimate elongation percentage before and after aging.
• [6] Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
• [7] Nitra-Touch™ examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standard
Dimensions	Meets ASTM D 3578
Physical Properties	Meets ASTM D 3578

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K982131|

Nitra-Touch™ Ansell Edmont Industrial. Inc. 1300 Walnut Street Coshocton, Ohio 43812 Telephone: [phone] Fax: [phone]

Except Ultimate Elongation meets specifications described under Attachment II

Freedom from holes Meets ASTM D 5151

Powder-Free Meets described test in Attachment V Original Ultimate Elongation 500% minimum Aged Ultimate Elongation 400% minimum

Meets ASTM D 3578

ASTM D 5250

ASTM D 3578

Not more than 2 mg residue by mass.

Tensile Strength MPa Tensile Strength 60% higher than vinyl (synthetic) examination gloves Vinyl = 10.5 Nitra-Touch™ = 17.1

Puncture lbf/in Puncture resistance of Nitra-TouchTM is eight (8) times greater than vinyl and nearly twice that of competitive nitrile gloves

Glutaraldehyde Resistance Nitrile film provides excellent chemical resistance to glutaraldehyde.

Permeation Rate = 480

Passes Passes

• [8] The performance test data of the non clinical tests are the same as mentioned immediately above.
• ld] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
• It is concluded that Nitra-Touch™ examination gloves are as safe, as effective, and [10] perform as well as the glove performance standards referenced in Section 7 above and therefore meet:

ASTM listed standards, FDA hole requirements, and labeling claims for the product.

• This summary will include any other information reasonably deemed necessary by The [1]] FDA.

2

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle symbol, which is a common emblem of the United States. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's full name and country.

OCT 2 9 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mike W. Hagans Ansell Edmont Industrial, Incorporated 1300 Walnut Street Coshocton, Ohio 43812

Re : K982131 Nitra-Touch™ Powder-Free Nitrile Medical Trade Name: Examination Glove Requlatory Class: I Product Code: LZA Dated: September 9, 1998 Received: September 21, 1998

Dear Mr. Hagans:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Hagans

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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3.0 Indications for Use Statement:

INDICATIONS FOR USE

Applicant:	Ansell Edmont Industrial, Inc.
510(K) Number (if known):	K982131 *

NITRA TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE

Device Name:	Patient Examination Glove
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Indications For Use:

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r 21 CFR 801.109

A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number	K982131
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Prescription Use	OR	Over-The-Counter	X
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