GLOVE, EXAMINATION, VINYL

K952050 · Oak Carolina, Inc. · LYZ · Aug 12, 1996 · General Hospital

Device Facts

• Record ID: K952050
• Device Name: GLOVE, EXAMINATION, VINYL
• Applicant: Oak Carolina, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Aug 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Their intended use is to prevent an interchange of body fluids via the hands of the wearer and the person (patient) being examined. Specifically, they are designed to prevent blood or other body fluids from the hands of the wearer from being transferred to the examinee. Also they are designed to prevent body fluids from the examinee from being transferred to the wearer via the wearer's hands.

Device Story

Sensi-tex vinyl examination gloves; worn on hands by healthcare personnel during patient examinations; barrier function prevents bidirectional transfer of blood and body fluids; reduces risk of cross-contamination; non-sterile; powder-free; no additives.

Clinical Evidence

Bench testing only; includes physical property testing (tensile strength, elongation, dimensions) per ASTM D5250, water leak testing per ASTM D5151-92, and biocompatibility studies confirming no primary skin irritation.

Technological Characteristics

Material: Poly vinyl chloride (vinyl). Dimensions: 230mm length; 92-124mm width. Tensile strength: 1310 PSI min. Elongation: 300% min. Thickness: 4-6 mils (finger), 9-13 mils (palm). Standards: ASTM D5250, ASTM D5151-92. Powder-free. No color/flavor additives.

Indications for Use

Indicated for use as a patient examination glove to prevent cross-contamination of body fluids between healthcare personnel and patients.

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.

Submission Summary (Full Text)

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EXHIBIT VII

OAK CAROLINA INC.

AUG 12 1996

April 26, 1996

K952050

Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center (HFZ-401)
9200 Corporate Boulevard
Rockville, Maryland 20850

Attention: To whom it may concern

Subject: Summary of Safety and Effectiveness Information for Oak Carolina Examination Gloves.

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Oak Carolina Inc.
100 Roe Road
Travelers Rest, S.C. 29690

Oak Carolina examination gloves are made from poly vinyl chloride (vinyl). They are to be marketed under the trade name Sensi-tex. Their intended use is to prevent an interchange of body fluids via the hands of the wearer and the person (patient) being examined. Specifically, they are designed to prevent blood or other body fluids from the hands of the wearer from being transferred to the examinee. Also they are designed to prevent body fluids from the examinee from being transferred to the wearer via the wearer's hands.

This product is donned or placed on the hands. Care should be taken to prevent rips and tears during donning and use.

The specifications for the gloves are as follows:

| Style Number | 96-160 | 96-260 | 96-360 | 96-460 |
| --- | --- | --- | --- | --- |
| Size | Small | Medium | Large | X-Large |
| Width | 92±5mm | 105±5mm | 114±5mm | 124 ± 5mm |
| Length(minimum) | 230mm | 230mm | 230mm | 230mm |
| Tensile(minimum) | 1310 PSI | 1310 PSI | 1310 PSI | 1310 PSI |
| Elongation(minimum) | 300% | 300% | 300% | 300% |
| *Thickness(range) | | | | |
| Finger | 4-6 mils | 4-6 mils | 4-6 mils | 4-6 mils |
| Palm | 9-13 mils | 9-13 mils | 9-13 mils | 9-13 mils |

The product meets the physical requirements specified above both before and after accelerated aging at $158 \pm 4.5^{\circ} \mathrm{F}$.

*Measured per ASTM D5250 Fig. 1

TRAVELERS REST, SOUTH CAROLINA 29690-9428 • 803-834-1239 • FAX [phone]

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This product when tested in accordance with ASTM D5151-92 meets the 1000 ml water test leak requirements.

This product contains no color or flavor additives. No dusting powder or donning powder is used in the manufacture of this product.

Biocompatibility studies demonstrate that this product is not a primary irritant to the skin.

This product, a vinyl examination glove is substantially equivalent in composition and function to other vinyl examination gloves.

Sincerely,

Greg Dempsey
Quality Assurance Manager