NITRILE POWDER-FREE EXAMINATION GLOVES

K023170 · Allegiance Healthcare Corp. · LZA · Oct 9, 2002 · General Hospital

Device Facts

• Record ID: K023170
• Device Name: NITRILE POWDER-FREE EXAMINATION GLOVES
• Applicant: Allegiance Healthcare Corp.
• Product Code: LZA · General Hospital
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Nitrile powder-free examination gloves; disposable; worn on examiner's hands/fingers. Function: barrier protection against cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Device provides physical barrier; no electronic or mechanical components.

Clinical Evidence

Bench testing only. Primary skin irritation and guinea pig maximization tests showed no irritation or sensitization potential. Tensile strength and barrier defect testing met or exceeded ASTM D6319-00a and 21 CFR 800.20 requirements.

Technological Characteristics

Material: Nitrile. Form: Powder-free, beaded. Standards: ASTM D6319-00a (tensile strength, barrier defects), 21 CFR 800.20 (barrier defects). Non-sterile, disposable.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner.

Regulatory Classification

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.

Predicate Devices

• Flexam Nitrile T Ambi Examination Gloves (K023170)

Submission Summary (Full Text)

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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§800.20<br>and 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.

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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: