ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE

K982505 · Tillotson Healthcare Corp. · LYY · Apr 2, 1999 · General Hospital

Device Facts

• Record ID: K982505
• Device Name: ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
• Applicant: Tillotson Healthcare Corp.
• Product Code: LYY · General Hospital
• Decision Date: Apr 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

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 are intended for use in situations where powder is not desirable.

Device Story

Natural rubber latex examination glove; provides barrier against body fluids and bloodborne pathogens; conforms to hand for medical treatment. Used in clinical settings by healthcare examiners. Device acts as physical barrier; no electronic or algorithmic components. Safety validated via rabbit irritation and guinea pig sensitization testing.

Clinical Evidence

No clinical data. Safety established via non-clinical bench testing including rabbit irritation and guinea pig sensitization studies, which passed. Performance testing confirmed compliance with ASTM D3578-95 (physical properties) and ASTM D5151-92 (water tightness).

Technological Characteristics

Natural rubber latex material. Conforms to ASTM D3578-95 for tensile properties and ASTM D5151-92 for water tightness. Non-sterile, powder-free, disposable form factor.

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

• Ultra Care Non-Sterile Powder Free Natural Rubber Latex Patient Examination Glove (K960247)

Submission Summary (Full Text)

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4/2/99

**SUMMARY OF 510(k) SUBMISSION** K982505

#### INFORMATION A. 1. SUBMITTER'S

- NAME:
ADDRESS:

TELEPHONE NUMBER:

CONTACT PERSON:

DATE SUMMARY PREPARED:

- 2. NAME OF DEVICE TRADE OR PROPRIETARY NAME:
COMMON OR USUAL NAME:

CLASSIFICATION NAME:

3. PREDICATE DEVICE IDENTIFICATION NAME, NUMBER

### TILLOTSON HEALTHCARE CORPORATION

360 Route 101

Bedford, NH 03110 U.S.A.

[phone]

Edward Markovic

July 20, 1998

Ultra Care Non-Sterlie Powder Free (GREEN) Natural Rubber Latex Patient Examination Glove

Examination Glove

Examination Glove

Ultra Care Non-Sterile Powder Free Natural Rubber Latex Patient Examination Glove K960247 1.Substantially Equivalent to Devices being marketed in the United States.

### 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 medical treatment.
- 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 glove is manufactured in accordance with the requirements of ASTM D3578-95 and ASTM D5151-92.

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# SUMMARY OF 510(K) SUBMISSION (cont.)

- 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 are intended for use in situations where powder is not desirable.
## 6. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE · The proposed product is equivalent to gloves currently being marketed in the U.S.

#### IF SE DECISION BASED ON PERFORMANCE DATA B.

- 1. DISCUSSION OF NON-CLINICAL TESTS

| SPECIFICATION | PROPOSED |
|--------------------------|---------------|
| PERFORMANCE<br>STANDARDS | ASTM D3578-95 |
| WATER TIGHTNESS | ASTM D5151-92 |

- 2. DISCUSSION OF CLINICAL TESTS

| SPECIFICATION | PROPOSED |
|--------------------------|----------|
| <i><b>SAFETY</b></i> | |
| RABBIT IRRITATION | Passes |
| GUINEA PIG SENSITIZATION | Passes |

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# SUMMARY OF 510(K) SUBMISSION (cont.)

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

- 3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
The Examination Glove has been carefully compared to legally marketed devices in the 510(k). The data summarles 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 medical glove.

Pursuant to 21 C.F.R. 807.87 ( ) ), I, Edward Markovic, Manager QA/Regulatory Affairs 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 Manager QA/Regulatory Affairs 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.

Edward Muskie

Edward Markovic Manager QA/Regulatory Affairs

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, arranged in a stacked formation. The profiles are connected by flowing lines, creating a sense of unity and movement. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1999

Edward Markovic Mr. QA/Requlatory Manager Tillotson Corporation 360 Route 101 Bedford, New Hampshire 03110

Re: K982505 Ultra Care Non-sterile Powder-Free (Green) Trade Name: Natural Rubber Latex Examination Gloves Requlatory Class: I Product Code: LYY Dated: January 4, 1999 Received: February 3, 1999

Dear Mr. Markovic:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Markovic

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (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 qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Piticus Curesitfor

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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510(K) Submission for Ultra Care Non-Sterile Powder Free (GREEN) Natural Rubber Latex Patient Examination Glove Submission Date: July 20, 1998 510(K) Number:

510(k) Number (if known):

K982505

Device Name:

Ultra Care Non-Sterile Powder Free (GREEN) Natural Rubber Latex Patient Examination Glove

# Indications For Use:

The Examination Glove is "a disposable device intended for medical purposes that is worn on the examiners 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)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)

Qian S. Lin

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