NITRILE POWDER-FREE EXAMINATION GLOVES

• K Number: K023170
• Device Name: NITRILE POWDER-FREE EXAMINATION GLOVES
• Manufacturer: ALLEGIANCE HEALTHCARE CORP.
• Date Cleared: 2002-10-09 ( 16 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Special
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A 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.

Device Description

Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Nitrile Powder-Free Examination Gloves" by Allegiance Healthcare Corporation. It is a submission for a medical device that does not involve AI or algorithms, and therefore, many of the requested categories are not applicable.

Here's the information based on the provided text, indicating "N/A" (Not Applicable) for categories that pertain to AI/algorithm-based devices:

Acceptance Criteria and Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Primary Skin Irritation	No irritation	Gloves show no irritation.
Guinea Pig Maximization	No potential for irritation	Gloves do not display any potential for irritation.
Tensile Strength	Meet or exceed requirements per ASTM D6319-00a	Gloves meet or exceed requirements per ASTM D6319-00a.
Barrier Defects	Meet or exceed requirements per 21 CFR§800.20 and ASTM D6319-00a	Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D6319-00a.

Study Details

1. Sample size used for the test set and the data provenance: Not specified, as this is a physical device rather than an AI/data-driven one. The tests are for physical properties and biocompatibility.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and biocompatibility tests would be established through standardized testing protocols executed by designated laboratory personnel, not clinical experts for ground truth in the AI sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The tests involve objective measurements and observations against established standards, not interpretation requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. For example:

   • Biocompatibility tests (Skin Irritation, Guinea Pig Maximization): "No irritation" or "no potential for irritation" as determined by standardized biological evaluation methods.
   • Tensile Strength: Measurements meeting specified values in ASTM D6319-00a.
   • Barrier Defects: Compliance with defect limits set in 21 CFR §800.20 and ASTM D6319-00a.

7. The sample size for the training set: Not applicable, as there is no training set for a physical device like examination gloves.

8. How the ground truth for the training set was established: Not applicable.

Summary

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XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

Allegiance

K023170

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NITRILE POWDER-FREE EXAMINATION GLOVES

Applicant/Sponsor: Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085

Regulatory Affairs Contact: Erica Sethi Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085

Telephone: [phone]

Date Summary Prepared: September 10, 2002

Product Trade Name: Undetermined

Common Name: Examination Glove

Classification: Patient Examination Glove

Predicate Devices: Flexam Nitrile T Ambi Examination Gloves, Allegiance Healthcare Corp.

Description: Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.

Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

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Substantial Equivalence: Nitrile Powder-Free Examination Gloves are substantially equivalent to Allegiance Healthcare's Flexam Nitrile T Ambi Examination Gloves in that they provide the following characteristics:

• same indication for use
• same sizes
• both made of nitrile
• both offered beaded and powder-free

Summary of Testing:

Test	Result
Primary Skin Irritation	Gloves show no irritation.
Guinea Pig Maximization	Gloves do not display any potential for irritation.
Tensile Strength	Gloves meet or exceed requirements per ASTM D6319-00a.
Barrier Defects	Gloves meet or exceed requirements per 21 CFR§800.20and ASTM D6319-00a.

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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 image of three stylized human profiles facing to the right, with three lines above them that resemble a bird in flight.

Public Health Service

OCT 0 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Erica Sethi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085

Re: K023170

Trade/Device Name: Nitrile Powder-Free Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LZA Dated: September 10, 2002 Received: September 23, 2002

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.

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.

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Page 2 - Ms. Sethi

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy 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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Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: [phone]

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Applicant:	Allegiance Healthcare Corporation
510(k) Number:	K023170
Device Name:	Undetermined Nitrile Powder-Free Examination Gloves

Indications For Use: A 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The-Counter Use

Les. Victorh

(Division Sign-Off) Division of Anesthestology, General Hospital, Infection Control, Dental Device

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.