TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE

K013016 · Tillotson Healthcare Corp. · LZA · Oct 19, 2001 · General Hospital

Device Facts

• Record ID: K013016
• Device Name: TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
• Applicant: Tillotson Healthcare Corp.
• Product Code: LZA · General Hospital
• Decision Date: Oct 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The True Advantage Non-Sterile Powder Free Purple Nitrile Patient Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

Device Story

Nitrile examination glove; serves as physical barrier against body fluids and bloodborne pathogens. Material properties conform to hand for dexterity during medical procedures. Manufactured via leaching process to remove chemical accelerants; powder-free with synthetic inner coating. Used in clinical settings by healthcare professionals. Provides protection against contamination; alternative for latex-sensitive individuals.

Clinical Evidence

No clinical data. Bench testing only. Device demonstrated compliance with ASTM D6319-00 (tensile properties), ASTM D5151-99 (water tightness), and ASTM D6499-00 (antigenic protein). Passed guinea pig sensitization and rabbit irritation testing.

Technological Characteristics

Nitrile rubber material; powder-free with synthetic inner coating. Dimensions and physical properties conform to ASTM D6319-00. Barrier integrity tested per ASTM D5151-99 and FDA 1000 mL water test. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner. Suitable for use in situations where healthcare worker or patient sensitivity to natural rubber latex is a factor.

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

• Pilgram Nitrile Latex, Non-Sterile Examination Glove (K905765A)

Submission Summary (Full Text)

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OCT 1 9 2001

[TAB #10]

Attachment #9

Summary of 510(k) Submission

#### A. INFORMATION

SUBMITTER'S 1.

NAME:

ADDRESS:

# TILLOTSON HEALTHCARE CORPORATION

Bedford, NH 03110 U.S.A.

360 Route 101

[phone]

F.W. Perrella

August 2001

Examination Glove

Examination Glove

TELEPHONE NUMBER:

CONTACT PERSON:

DATE SUMMARY PREPARED:

- NAME OF DEVICE 2. TRADE OR PROPRIETARY NAME:
True Advantage Non-Sterile Powder Free Purple Nitrile Examination Glove

COMMON OR USUAL NAME:

CLASSIFICATION NAME:

- PREDICATE DEVICE IDENTIFICATION 3. NAME, NUMBER
1. Pilgram Nitrile Latex, Non-Sterile

Examination Glove K905765A

#### DESCRIPTION OF 4.

DEVICE

- a. HOW THE DEVICE FUNCTIONS: Nitrile films form a barrier to body fluids and bloodborne Pathogens.
- b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: The nitrile rubber is water tight under normal conditions of use. It's tensile Properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
- PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, C. MATERIALS AND PHYSICAL PROPERTIES: Nitrile Rubber is known to create a barrier to bloodborne pathogens and and body fluids. ASTM D6319 conforming tensile properties create a glove that

510(k) Sub. - True Advantage Powder Free Purple Nitrile Examination Glove with 2 milligrams or less of Total Particulate per Glove. Submission Date: August 2001 510(k) Number:_########

Koi 3016

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Is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D6319-00 and ASTM D5151-99 requirements.

- STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR న్. CONDITIONS THAT THE DEVICE WILL
ADDRESS

This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Nitrile Examination gloves are suitable in situations where healthcare worker or patient natural rubber latex allergic sensitivity may be a factor.

- EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE 6.
The modified product was made powder free and has a color change compared to the predicate product.

The modified product has no starch donning powder added, a synthetic inner coating, and a purple color in contrast to the white powdered predicate product claim.

## B. IF THE DECISION BASED ON PERFORMANCE

#### DATA

2.

- 1. DISCUSSION OF NON-CLINICAL TESTS
SPECIFICATION

PROPOSED Synthetic inner coating with no starch donning powder added and with a purple color claim

#### PREDICATE

No synthetic inner coating, but white in color, and with starch donning powder added

| PERFORMANCE STANDARDS | ASTM D6319-00a ASTM D3578-88 |
|-----------------------|-------------------------------------------|
| WATER TIGHTNESS | ASTM D5151-99 1988 FDA 1000 mL Water Test |
| ANTIGENIC PROTEIN | ASTM D6499-00 |

DISCUSSION OF CLINICAL TESTS

| SPECIFICATION | PROPOSED | PREDICATE |
|---------------|----------|-----------|
| SAFETY | | |

PASSES

PASSES

PASSES

PASSES

GUINEA PIG SENSITIZATION

RABBIT IRRITATION

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#### 3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE

SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT

The True Advantage Powder Free Purple Nitrile Examination Glove has been carefully compared to legally marketed devices in the 510(k).

The data summaries indicate that the proposed product meets or exceeds acceptable scores for the predicate product in nonclinical tests, and satisfies the requirements for a safe and effective, no starch donning powder added with 2 milligrams or less of total particulate purple examination glove claim.

Pursuant to 21 C.F.R. 807.87 ( i ), I. F.W. Perrella. Ph.D., Vice President R&D certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the V.P. R&D for TILLOTSON HEALTHCARE CORPORATION, and in reliance thereupon, the data and information submitted in this of the substantial equivalence of this device have been knowingly omitted from this Submission.

F.W. Perrella, Ph.D. Vice President R&D

Signature

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract caduceus or a symbol representing health and human services. The symbol consists of three curved lines that converge and flow together.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 9 2001

Mr. Frank W. Perralla, Ph. D. Vice President, Research and Development Tillotson Healthcare Corporation 360 Route 101 Bedford, New Hampshire 03110

Re: K013016

Trade/Device Name: True Advantage Non-Sterile Powder Free Purple Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Examination Gloves Regulatory Class: I Product Code: LZA Dated: August 31, 2001 Received: September 7, 2001

Dear Dr. Perrella:

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 - Dr. Perrella

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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Les Walcott

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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- Indications for Use Statement: Include the following or equivalent Indications for Use page. 3.0 The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
### INDICATIONS FOR USE

| Applicant: | Tillotson Healthcare Corporation |
|-----------------------------|----------------------------------|
| 5 10(k) Number (if known):* | K013016 |

True Advantage Non-Sterile Powder Free Purple Nitrile Examination Device Name: Glove

Indications For Use:

The True Advantage Non-Sterile Powder Free Purple Nitrile Patient Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Chin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

Prescription Use OR Over-The-Counter Per 21 CFR 801.109 (Optional Format 1-2-96)

For a new submission, do NOT fill in the 510(k) number blank.