CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA

K013286 · Tillotson Healthcare Corp. · LYY · Oct 12, 2001 · General Hospital

Device Facts

• Record ID: K013286
• Device Name: CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA
• Applicant: Tillotson Healthcare Corp.
• Product Code: LYY · General Hospital
• Decision Date: Oct 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Cymunvera Powder Free Green Natural Rubber Latex Examination Glove lined with Aloe Vera 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

Disposable natural rubber latex examination glove; worn on examiner's hand; acts as physical barrier against body fluids and bloodborne pathogens; prevents cross-contamination between patient and examiner. Device features aloe vera lining; green color; powder-free. Manufactured via leaching process to reduce proteins and chemical accelerants. Used in clinical settings by healthcare professionals. Provides flexible, water-tight barrier conforming to hand for medical procedures.

Clinical Evidence

No clinical data. Safety and effectiveness supported by non-clinical bench testing, including water tightness (ASTM D5151-99), physical properties (ASTM D 3578-00a), and biocompatibility (rabbit irritation and guinea pig sensitization studies).

Technological Characteristics

Natural rubber latex; powder-free; green color; aloe vera lining. Conforms to ASTM D 3578-00a and ASTM D5151-99. Barrier function based on water-tight latex film. Leaching process used to reduce residual proteins and chemical accelerants.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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

• Accutouch Powder Free Natural Rubber Latex Examination Glove (K992428)

Submission Summary (Full Text)

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OCT 1 2 2001

510(K) Sub. - CYMUNVERA Powder Free Green Latex Patient Exam Glove Submission Date: August 27, 2001 510(K) Number:_

[TAB #11]

K013286

ATTACHMENT #9

CYMUNVERA Powder Free Green Natural Rubber Latex Patient Examination Glove lined with Aloe Vera SUMMARY OF 510(k) Submission

- INFORMATION A. 1. SUBMITTER'S
2. NA

3. PRI

| NAME: | TILLOTSON HEALTHCARE CORPORATION |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------|
| ADDRESS: | 360 Route 101<br>Bedford, NH 03110 U.S.A. |
| TELEPHONE NUMBER: | [phone] |
| CONTACT PERSON: | Thomas N Tillotson |
| DATE SUMMARY PREPARED: | April 18, 2001 |
| NAME OF DEVICE<br>TRADE OR PROPRIETARY NAME: | Cymunvera Powder Free Green Natural<br>Rubber LatexExamination Gloves lined with<br>Aloe Vera |
| COMMON OR USUAL NAME: | Examination Glove |
| CLASSIFICATION NAME: | Examination Glove |
| PREDICATE DEVICE IDENTIFICATION<br>NAME, NUMBER | 1. Accutouch Powder Free Natural Rubber<br>Latex Examination Glove K992428 |

4. DESCRIPTION OF DEVICE

- a. HOW THE DEVICE FUNCTIONS: Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens.
- b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: The natural 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.
- c. PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS AND PHYSICAL PROPERTIES: Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of Proteins and chemical

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accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D 3578-00a and ASTM D5151-92 requirements

- 5. STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR 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. Powder free gloves eliminate issues of powder contamination.

- 6. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE The product has similar properties compared to the predicate product. It is suitable for situations where a powder free, NRL glove is desirable.
It is green compared to the white color of the predicate product

- B. IF SE DECISION BASED ON PERFORMANCE
DATA

SENSITIZATION

1. DISCUSSION OF NON-CLINICAL TESTS

| SPECIFICATION | PROPOSED | PREDICATE |
|------------------------------------|------------------|------------------|
| | Powder Free | Powder Free |
| | Green Color | White Color |
| PERFORMANCE<br>STANDARDS | ASTM D 3578-00a | ASTM D 3578-99 |
| WATER TIGHTNESS | ASTM D5151-99 | ASTM D5151-99 |
| 2. DISCUSSION OF<br>CLINICAL TESTS | | |
| SPECIFICATION<br>SAFETY | PROPOSED | PREDICATE |
| RABBIT IRRITATION<br>GUINEA PIG | Passes<br>Passes | Passes<br>Passes |

## DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED with specific reference to adverse effects and complications

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- 3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
The Cymunvera, 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 powder free, natural rubber latex medical glove.

Pursuant to 21 C.F.R. 807.87 ( j ), I, Thomas N Tillotson, CEO, 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 CEO for TILLOTSON HEALTHCARE CORPORATION,

and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.

Thomas N. Tilletson

Thomas N Tillotson CEO

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2001

Tillotson Healthcare Corporation C/O Mr. Mark Job Responsible Third Party Official TUV Products Service, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K013286

Trade/Device Name: Cymunvera Powder Free Green Natural Rubber Latex Patient Examination Glove Lined with Aloe Vera Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 1, 2001 Received: October 2, 2001

Dear Mr. Job:

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

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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 and additionally hand [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,

[signature]

Tin Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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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):* | K013286 |

Cymunvera Powder Free Green Natural Rubber Latex Examination Device Name: Glove lined with Aloe Vera

Indications For Use:

Cymunvera Powder Free Green Natural Rubber Latex Examination Glove lined with Aloe Vera 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)

Qhis S. hm
(Division Sign-Off)

ntal Infection 510(k) Numbe

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.