(469 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No
The device, examination gloves, is intended to prevent the transfer of body fluids, not to treat or diagnose a medical condition.
No
The device, examination gloves, is intended to prevent the transfer of body fluids, not to diagnose a condition. Its function is barrier protection.
No
The device description clearly states the device is made from poly vinyl chloride (vinyl) and is an examination glove, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent the transfer of body fluids between the wearer's hands and the patient during examination. This is a barrier function, not a diagnostic function. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is an examination glove made of poly vinyl chloride. This is a physical barrier, not a reagent, instrument, or system used for in vitro testing.
- Performance Studies: The performance studies focus on leak resistance and biocompatibility, which are relevant to the barrier function and safety of a glove, not the analytical or clinical performance of a diagnostic test.
The description clearly indicates that these are examination gloves intended for barrier protection, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
Oak Carolina examination gloves are made from poly vinyl chloride (vinyl). They are to be marketed under the trade name Sensi-tex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
This product when tested in accordance with ASTM D5151-92 meets the 1000 ml water test leak requirements.
Biocompatibility studies demonstrate that this product is not a primary irritant to the skin.
Key Metrics
| 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 |
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
AUG 12 1996
Image /page/0/Picture/2 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. The words "CAROLINA INC." are to the right of the logo in a bold, sans-serif font.
April 26, 1996
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 | $92\pm5mm$ | $105\pm5mm$ | $114\pm5mm$ | $124 \pm 5mm$ |
| 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 ±4.5ºF.
*Measured per ASTM D5250 Fig. 1
1
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,
Guy Dempsey
Greg Dempsey Quality Assurance Manager