POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM

K012149 · Allegiance Healthcare Corp. · LYY · Sep 24, 2001 · General Hospital

Device Facts

• Record ID: K012149
• Device Name: POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM
• Applicant: Allegiance Healthcare Corp.
• Product Code: LYY · General Hospital
• Decision Date: Sep 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.

Device Story

Disposable natural rubber latex examination glove; polymer-coated; non-sterile. Worn by healthcare professionals during patient examinations to provide a barrier against contamination. Tested for resistance to chemotherapy drugs per ASTM F 739-99a. Provides protection for both patient and examiner; reduces risk of protein sensitization due to low protein content (≤50 µg/g).

Clinical Evidence

Bench testing only. Compliance with ASTM D3578-00 for physical dimensions, tensile strength, and elongation. Barrier defects tested per 21 CFR 800.20 (AQL=2.5). Protein content verified ≤50 µg/g using ASTM D5712-95 (Lowry method). Chemotherapy resistance tested per ASTM F 739-99a. Biocompatibility confirmed via primary skin irritation and sensitization testing (Guinea Pig Maximization).

Technological Characteristics

Material: Natural rubber latex with polymer coating. Dimensions/Sizes: X-small, Small, Medium, Large, X-large. Standards: ASTM D3578-00 (physical properties, powder-free designation), ASTM D5712-95 (protein content), ASTM F 739-99a (chemotherapy drug permeation), 21 CFR 800.20 (barrier defects). Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner. Suitable for use with chemotherapy drugs. No specific age or gender restrictions.

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

• Positive Touch Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim (10/214)

Submission Summary (Full Text)

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SEP 2 4 2001

Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a stylized font. The word is written in black and appears to be slightly italicized. There is a symbol to the left of the word that looks like a plus sign made up of small circles.

### STATEMENT OF SAFETY AND EFFECTIVENESS XIII.

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

Manufacturer:

Allegiance Healthcare Sdn. Bhd. Plot 87 Kampung Jawa Bayan Lepas Penang, West Malaysia 11900

Regulatory Affairs Contact:

Erica Sethi 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085

Telephone:

[phone]

June 21, 2001

Date Summary Prepared:

Common Name:

Classification:

Predicate Devices:

Description:

Intended Use:

Patient Examination Glove

Glove, Examination (Latex)

Positive Touch Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim

10/214

Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are formulated using latex and are coated with a Polymer coating. These gloves are offered non-sterile in sizes X-small, Small, Medium, Large and X-large.

Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim 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 gloves have been tested for use with chemotherapy drugs using ASTM F 739-99a.

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Image /page/1/Picture/0 description: The image contains the word "Allegiance" in a stylized font. To the left of the word is a symbol that resembles a plus sign made up of small squares. The word "Allegiance" is written in a dark color, possibly black or a dark shade of gray. The font appears to be bold and slightly italicized.

#### STATEMENT OF SAFETY AND EFFECTIVENESS XIII.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (con't) POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM

Substantial Equivalence

Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are substantially equivalent to Positive Touch Powder-Free Latex Examination Gloves in that they provide the following characteristics:

- intended use
- size, design, product features
- made of natural rubber latex
- physical characteristics

Summary of Test Results:

Test

Result

Glove does not display irritation potential.

Glove does not display sensitization potential. Guinea Pig Maximization

Ultimate Elongation & Tensile Strength

Primary Skin Irritation

Barrier Defects

Powder Level

Protein Labeling Claim

Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-00.

Glove meets or exceeds requirements per 21 CFR \$800.20 and ASTM D3578-00, AQL=2.5.

Glove meets powder level requirements for "Powder Free" designation per ASTM D 3578-00.

Glove meets requirements for protein claim of 50 microgram or less of total water extractable protein per gram of glove using the ASTM Lowry test method (ASTM 5712-95).

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2001

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

Re: K012149

Trade/Device Name: Powder-Free Latex Examination Gloves with Protein, Chemotherapy Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: June 21, 2001 Received: July 10, 2001

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 (section 531-542 of the Act; 21); CFR 1000-1050.

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 regulation (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" (21CFR 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.

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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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a symbol that resembles a plus sign, but it is made up of many small dots. The word is in black, and the background is white.

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

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| Applicant: | Allegiance Healthcare Corporation |
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| 510(k) Number: | K012149 |
| Device Name: | Powder-Free Latex Examination Gloves With Protein, Chemotherapy 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. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use __________<br>(Per 21 CFR 801.109) | or | Over-The Counter Use __________ |
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(Division Sign-Off) (Division Sign-Un)
Division of Dental, Infection Control,
Division of Dental, Devices Division of Dollars and General Hospital V 015 510(k) Number ------