(50 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related computational processing.
No
The device, a patient examination glove, is intended for prevention of contamination, not for diagnosing, treating, or alleviating a medical condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnostic function. The performance studies listed are related to the physical properties of the glove, not its ability to diagnose.
No
The device description clearly states it is a "powder free vinyl examination glove," which is a physical hardware device, not software. The performance studies also focus on physical characteristics like tensile strength, elongation, and thickness.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner." This describes a barrier device used for infection control during physical examinations.
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Lack of IVD Characteristics: The description and performance data provided do not mention any analysis of human specimens, diagnostic testing, or any other activities typically associated with IVDs. The tests performed (Water Leak, Tensile, Elongation, Thickness, Length, Width, Powdered) are related to the physical properties and barrier function of the glove, not diagnostic capabilities.
Therefore, this device is a medical device, but it falls under the category of a barrier device for infection control, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
This device is a powder free vinyl examination glove.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of technological characteristics and non-clinical performance data was conducted against a predicate device.
Key results:
- Water Leak Test ASTM D5151-92: Pass
- Tensile MPa Ultimate: 10.1
- Elongation, Ultimate (%): 326
- Thickness - Palm (mm): .178
- Thickness - Finger (mm): .125
- Length (mm): 241
- Width (mm): S, M, L, XL (95, 105, 118, 124)
- Powdered: No
- ASTM 5250-92: Meets* ASTM 5250-92 (Except for (width) dimensional requirements.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
(02
Page: 10.1
510(k) Summary
Summary of 510(k) Safety and Effectiveness Information
| Submitter: | Oak Carolina (Darrell Alford)
Division of Oak Technical |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitters Address: | 100 Roe Road
Travelers Rest, SC 29690 |
| Date Prepared: | May 29, 1998 |
| Submitters Phone Number: | (864) 834-1239 |
| Submitters Fax Number: | (864) 834-1219 |
| 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
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
medical purposes that is worn on the examiners hand to prevent
contamination between patient and examiner |
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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
96-X60 Series | Maxxim
Vinyl Exam Glove |
|----------------------------------|---------------------------------------|----------------------------|
| Water Leak Test
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
95, 105, 118, 124 | L
105 |
| Powdered | No | No |
| ASTM 5250-92 | Meets*
ASTM 5250-92 | Meets
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
3
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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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 803-854-1219