DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

K024102 · Allegiance Healthcare Corp. · LYY · Dec 18, 2002 · General Hospital

Device Facts

• Record ID: K024102
• Device Name: DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
• Applicant: Allegiance Healthcare Corp.
• Product Code: LYY · General Hospital
• Decision Date: Dec 18, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for 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. These Dental Latex Examination Gloves are intended specifically for Dentistry and will be worn during dental cleaning, filling and examination in non-sterile environments within hospitals and other healthcare facilities.

Device Story

Dental Powder-Free Latex Examination Gloves are disposable, non-sterile, hand-specific natural rubber latex gloves. Used by dental professionals in hospitals and healthcare facilities during dental cleaning, filling, and examination procedures. The gloves act as a physical barrier to prevent contamination between the patient and the examiner. They are manufactured to meet specific tensile strength, elongation, and barrier defect standards to ensure clinical utility and patient protection.

Clinical Evidence

Bench testing only. Testing included primary skin irritation and guinea pig maximization studies, which showed no potential for irritation. Physical performance testing confirmed compliance with ASTM D3578-01 for ultimate elongation, tensile strength, and barrier defects (per 21 CFR 800.20).

Technological Characteristics

Natural rubber latex; non-sterile; hand-specific; powder-free. Meets ASTM D3578-01 standards for tensile strength, elongation, and barrier integrity. Complies with 21 CFR 800.20 for barrier defects.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner during dental procedures, including cleaning, filling, and examination in non-sterile healthcare environments.

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

• Dental Latex Powdered Examination Gloves

Submission Summary (Full Text)

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# XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

Allegiance

K024102

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

Manufacturer: Allegiance Healthcare Corporation 1500 Waukegan road McGaw Park, IL 60085

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

Telephone: [phone]

Date Summary Prepared: 11/20/02

Product Trade Name: Undetermined

Common Name: Examination Glove

Classification: Patient Examination Glove

Predicate Devices: Dental Latex Powdered Examination Gloves

Description: Dental Powder-Free Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.

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. These Dental Latex Examination Gloves are intended specifically for Dentistry and will be worn during dental cleaning, filling and examination in non-sterile environments within hospitals and other healthcare facilities.

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Substantial Equivalence: The Dental Powder-Free Latex Examination Gloves With Protein Labeling Claim are substantially equivalent to Dental Latex Powdered Examination Gloves in that they provide the following characteristics:

- same intended use
- same sizes, configuration, packaging
- both made of natural rubber latex
- same tensile strength and thickness profiles
- both hand specific non-sterile examination gloves

## Summary of Testing:

| Test | Result |
|-------------------------------------------|----------------------------------------------------------------------------------------|
| Primary Skin Irritation | Gloves do not display any potential for irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Ultimate Elongation<br>& Tensile Strength | Gloves meet or exceed requirements for rubber examination<br>gloves per ASTM D3578-01. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR<br>§800.20 and ASTM D 3578-01. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Ms. Erica Sethi Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building K McGraw Park, Illinois 60085

Re: K024102

Trade/Device Name: Dental Powder-Free Latex Examination Gloves with Protein Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 20, 2002 Received: December 12, 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 vour 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 - Ms. Sethi

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 [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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Larson

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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**Allegiance**

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:

Device Name:

Dental Powder-Free Latex Examination Gloves With Protein Labeling Claim

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

Clins S. Com

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number K024102