(71 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a medical glove, with no mention of AI or ML technologies.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The intended use of the device is described as "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This function is for protection and hygiene, not for identifying a disease or condition. The performance studies also focus on physical properties of the glove (e.g., water leak, tensile strength, thickness) rather than diagnostic accuracy.
No
The device is a physical examination glove, not a software application. The description and performance studies focus on material properties and physical dimensions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device used externally.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description and performance data focus on physical properties of the glove (water leak, tensile strength, dimensions, etc.) and its function as a barrier. There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing body fluids or tissues.
Therefore, this device fits the description of a medical device used for protection and hygiene, 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 finger 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| TEST | OAK Vinyl Exam Glove 96-X61 Series | Maxxim Vinyl Exam Glove |
|---|---|---|
| Water Leak Test ASTM D5151-92 | Pass | Pass |
| Tensile MPa Ultimate | 10.4 | 13.7 |
| Elongation, Ultimate (%) | 355 | 437 |
| Thickness - Palm (mm) | .151 | .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.
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.
Maxxim powder free vinyl examination glove. (Note: K/DEN not provided for predicate device in the text)
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
7 1998 JUL
DAY CAROLINA INC.
f
Page: 10.1
510(k) Summary K981488
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 296910 |
| Date Prepared: | April 24, 1998 |
| Submitters Phone Number: | (864) 834-1239 |
| Submitters Fax Number: | (864) 834-1219 |
| Trade Name: | OAKTEX 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. |
1
INA INC.
510(k) Summary (98) 488
Technological characteristics and non-clinical performance data comparison of device to predicate device:
| TEST | OAK Vinyl Exam Glove
96-X61 Series | Maxxim
Vinyl Exam Glove |
|----------------------------------|---------------------------------------|----------------------------|
| Water Leak Test
ASTM D5151-92 | Pass | Pass |
| Tensile MPa Ultimate | 10.4 | 13.7 |
| Elongation, Ultimate (%) | 355 | 437 |
| Thickness - Palm (mm) | .151 | .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.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces left and is enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
7 1998 11 11
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Darrell W. Alford Quality Assurance Manager OAK Carolina, Incorporated Division of Oak Technical 100 Roe road Travelers Rest, South Carolina 29690
K981488 Re : OAKTEX PowderFree Vinyl Patient Examination Trade Name: Glove Regulatory Class: I Product Code: LYZ Dated: April 24, 1998 Received: April 27, 1998
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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਜ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure ________
4
Image /page/4/Picture/3 description: The image shows the logo for OAK CAROLINA INC. The word "OAK" is in a bold, sans-serif font and is enclosed in an oval shape. To the right of the logo is the text "CAROLINA INC." also in a bold, sans-serif font.
Revised Page 8.2
�
510(k) Number if known): K981488
Device Name: Oaktex Powder Free Vinyl Patient 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 finger 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)
Chen S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Innection of
510(k) Number K981488
Prescription Use
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
TRAVELERS REST, SQUTH CAROLINA 29690-9426 · 866-834-1239 · FAX 864-834-12 19