SENSITEX EXAMINATION GLOVE

K981963 · Oak Carolina, Inc. · LYZ · Jul 24, 1998 · General Hospital

Device Facts

• Record ID: K981963
• Device Name: SENSITEX EXAMINATION GLOVE
• Applicant: Oak Carolina, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

This patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner

Device Story

SensiTex Examination Glove is a powder-free vinyl glove; used by healthcare examiners to prevent cross-contamination between patient and examiner. Device acts as a physical barrier; worn on hands/fingers during medical examinations. No complex processing or electronic components involved.

Clinical Evidence

Bench testing only. Performance data includes water leak testing (ASTM D5151-92), tensile strength (10.1 MPa), elongation (326%), and dimensional measurements (palm/finger thickness, length, width). Device meets ASTM 5250-92 standards.

Technological Characteristics

Material: Vinyl. Powder-free. Dimensions: 241mm length; palm thickness 0.178mm; finger thickness 0.125mm. Standards: ASTM D5151-92 (water leak), ASTM 5250-92 (general specifications). Non-sterile, disposable.

Indications for Use

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

• Maxxim powder free vinyl examination glove

Reference Devices

• Sensicare powder free medical glove

Submission Summary (Full Text)

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JUL 2 4 1998

Image /page/0/Picture/1 description: The image shows the logo for Oak Carolina Inc. The word "OAK" is in bold, black letters inside of a horizontally oriented oval. To the right of the logo is the text "CAROLINA INC." in bold, black letters.

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Page: 10.1

## 510(k) Summary

# Summary of 510(k) Safety and Effectiveness Information

| Submitter: | Oak Carolina (Darrell Alford)<br>Division of Oak Technical |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitters Address: | 100 Roe Road<br>Travelers Rest, SC 29690 |
| Date Prepared: | May 29, 1998 |
| Submitters Phone Number: | [phone] |
| Submitters Fax Number: | [phone] |
| Trade Name: | SensiTex Examination Glove |
| Common Name: | Vinyl Examination Glove |
| Classification Name: | Vinyl Patient Examination Glove |
| Substantial Equivalence: | This device is substantially equivalent to the Maxxim powder free vinyl<br>examination glove. |
| Device Description: | This device is a powder free vinyl examination glove. |
| Intended Use of the Device: | This patient examination glove is a disposable device intended for<br>medical purposes that is worn on the examiners hand to prevent<br>contamination between patient and examiner |

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K981963

Image /page/1/Picture/1 description: The image shows the logo for OAK CAROLINA INC. The word "OAK" is in a stylized font and is surrounded by an oval shape. To the right of "OAK" is the text "CAROLINA INC.", with all letters capitalized and in a bold font.

Page: 10.2

### 510(k) Summary

Technological characteristics and non-clinical performance data comparison of device to predicate device:

| TEST | OAK Vinyl Exam Glove<br>96-X60 Series | Maxxim<br>Vinyl Exam Glove |
|----------------------------------|---------------------------------------|----------------------------|
| Water Leak Test<br>ASTM D5151-92 | Pass | Pass |
| Tensile MPa Ultimate | 10.1 | 13.7 |
| Elongation, Ultimate (%) | 326 | 437 |
| Thickness - Palm (mm) | .178 | .130 |
| Thickness - Finger (mm) | .125 | .113 |
| Length (mm) | 241 | 241 |
| Width (mm) | S, M, L, XL<br>95, 105, 118, 124 | L<br>105 |
| Powdered | No | No |
| ASTM 5250-92 | Meets*<br>ASTM 5250-92 | Meets<br>ASTM 5250-92 |

* Except for (width) dimensional requirements.

Conclusion drawn from technological characteristics and non-clinical testing:

We conclude that the Oak vinyl exam glove is substantially equivalent to the legally marketed Sensicare powder free medical glove based on the performance data comparison and technological characteristics.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 1998

Mr. Darrell W. Alford Quality Assurance Manager OAK Carolina, Incorporated Division of Oak Technical 100 Roe Road 29690 Travelers Rest, South Carolina

Re : K981963 SensiTex Vinyl Examination Glove Powder-Free Trade Name: Requlatory Class: I Product Code: LYZ Dated: May 29, 1998 June 4, 1998 Received:

Dear Mr. Alford:

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 reqistration, 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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. Alford

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 general 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,

S. Sutman for

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 contains the logo for "OAK CAROLINA INC.". The word "OAK" is in a stylized font and enclosed in an oval shape. The words "CAROLINA INC." are to the right of "OAK" in a bold, sans-serif font.

Ref: Page: 8.2 Page 6 of 6 K981963 (510k)

#### Statement of Indications For Use

510(k) Number (if known): K981963

Device Name: SensiTex Powder Free Vinyl Examination Glove

Indications For Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

#### (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 /

(Optional Format 1-2-96)

Olin S. him

Division Sign-Off) ivision of Dental, Infection Control, nd General Hospital Device

TRAVELERS REST, SOUTH CAROUNA 29593-8428 · BC3-634-1239 FAX [phone]