POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS

K020818 · Allegiance Healthcare Corp. · LYY · Jul 5, 2002 · General Hospital

Device Facts

• Record ID: K020818
• Device Name: POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
• Applicant: Allegiance Healthcare Corp.
• Product Code: LYY · General Hospital
• Decision Date: Jul 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder-Free Latex 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 gloves contain 50 micrograms or less of total water extractable protein per gram. These gloves have been tested for use with chemotherapy drugs.

Device Story

Disposable non-sterile patient examination glove; manufactured from natural rubber latex with colorants. Worn by healthcare examiners to provide barrier protection against contamination between patient and examiner. Tested for use with chemotherapy drugs. Provides low-protein profile (≤ 50 micrograms/gram). Used in clinical settings; manual operation by healthcare personnel.

Clinical Evidence

Bench testing only. Testing included primary skin irritation, guinea pig maximization for sensitization, ultimate elongation and tensile strength (ASTM D3578-01), barrier defects (21 CFR §800.20, AQL=2.5), powder levels (ASTM D3578-01), and protein content (ASTM D5712-99 Lowry method). Results confirmed compliance with all specified standards.

Technological Characteristics

Material: Natural rubber latex with colorants. Form factor: Powder-free examination glove. Standards: ASTM D3578-01 (physical properties, powder levels), ASTM D5712-99 (protein content). Barrier performance: AQL=2.5 per 21 CFR §800.20. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Suitable for use with chemotherapy drugs. Contains ≤ 50 micrograms of total water extractable protein per gram.

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

• Polymer Coated Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim

Submission Summary (Full Text)

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K 020818

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Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a stylized font. The word is written in a dark color, possibly black or a dark shade of gray. To the left of the word, there is a symbol that looks like a plus sign or a cross, made up of small squares or dots.

#### STATEMENT OF SAFETY AND EFFECTIVENESS XIII.

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS

| Manufacturer: | Allegiance Healthcare Corporation<br>1500 Waukegan Road, Bldg. WM<br>McGaw Park, Illinois<br>USA 60085 | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Regulatory Affairs Contact: | Erica Sethi<br>1500 Waukegan Road, Bldg. WM<br>McGaw Park, IL 60085 | |
| Telephone: | [phone] | |
| Date Summary Prepared: | February 12, 2002 | |
| Common Name: | Patient Examination Glove | |
| Classification: | Glove, Examination (Latex) | |
| Predicate Devices: | Polymer Coated Powder-Free Latex Examination Gloves With Protein<br>and Chemotherapy Labeling Claim | |
| Description: | Powder Free Examination Gloves are formulated using latex and have<br>colorants. These gloves are offered non-sterile. | |
| Intended Use: | Powder-Free Latex Examination Gloves are disposable devices<br>intended for medical purposes that are worn on the examiner's hands<br>or fingers to prevent contamination between patient and examiner.<br>These gloves contain 50 micrograms or less of total water extractable<br>protein per gram. These gloves have been tested for use with<br>chemotherapy drugs. | |

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Image /page/1/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KO2O818". The characters are written in a handwritten style, with varying stroke thicknesses. The characters are all connected, and the overall appearance is somewhat stylized.

Image /page/1/Picture/1 description: The image shows the word "Allegiance" in a stylized font. The word is written in a dark color, possibly black or a dark shade of gray. To the left of the word, there is a symbol that looks like a plus sign or a cross, also in the same dark color as the word.

#### STATEMENT OF SAFETY AND EFFECTIVENESS XIII.

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

| Substantial Equivalence | Powder Free Examination Gloves with colorants are substantially |
|-------------------------|-------------------------------------------------------------------|
| | equivalent to Polymer Coated Powder-Free Latex Examination Gloves |
| | in that they provide the following characteristics: |
| | - intended use |
| | - design, product features |
| | - made of natural rubber latex |
| | |

- physical characteristics

Summary of Test Results:

| Test | Result |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Skin Irritation | Glove does not display irritation potential. |
| Guinea Pig Maximization | Glove does not display sensitization potential. |
| Ultimate Elongation<br>& Tensile Strength | Glove meets or exceeds requirements for rubber<br>examination gloves per ASTM D3578-01. |
| Barrier Defects | Glove exceeds requirements per 21 CFR<br>§800.20 and ASTM D3578-01, AQL=2.5. |
| Powder Level | Glove meets powder level requirements for “Powder Free”<br>designation per ASTM D 3578-01. |
| Protein Labeling Claim | Glove meets requirements for protein claim of 50 microgram or less<br>of total water extractable protein per gram of glove using the ASTM<br>Lowry test method (ASTM 5712-99). |

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### JUL 5 2002

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

Re: K020818

Trade/Device Name: Powder-Free Brown Latex Examination Glove (Tested for Use With Chemotherapy Drugs) with Protein Content Labeling Claim ( 50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 15, 2002 Received: April 18, 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.

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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 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.

Susan Purses

Timothy A. Ulatowski 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

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

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Applicant: Allegiance Healthcare Corporation

KO20818 510(k) Number:

Powder-Free Brown Latex Examination Glove (Tested For Use With Chemotherapy Drugs) With Protein Content Labeling Claim (50 micrograms or less) Device Name:

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 | |

| (Division Sign-Off) |
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| Division of Dental, Infection Control,<br>and General Hospital Devices |

510(k) Number .