(69 days)
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Not Found
No
The document describes a standard examination glove and contains no mention of AI, ML, or any related technologies.
No
Explanation: The device is described as a disposable patient examination glove used by healthcare personnel to prevent contamination between patient and examiner, not for treating a disease or condition.
No
The device, a disposable examination glove, is for preventing contamination between patient and examiner, not for diagnosing medical conditions.
No
The device description clearly states it is a physical glove, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect healthcare personnel and prevent contamination between patient and examiner. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the material and protein content of the glove, which are relevant to its barrier properties and potential for allergic reactions, not diagnostic capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- No Mention of Image Processing, AI, or Machine Learning: These are often associated with advanced diagnostic devices, and their absence further supports that this is not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Ostar D'Pro glove does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Ostar D'Pro glove is a disposable patient examination glove intended to be worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Ostar D'Pro Latex Powdered Examination Gloves, Protein Claim of 100 mcgm or less of Total Water Extractable Protein Per Gram
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or birds in flight, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1998
Mr. Vina Ramalingam Contract Latex Dippers Sdn. Bhd. No. 11, 2nd Floor Jalan Sri Hartamas 7, 50480 Kuala Lumpur, MALAYSIA
K983568 Re : Ostar D'Pro Latex Powdered Examination Trade Name: Gloves, Protein Claim of 100 mcgm or less of Total Water Extractable Protein Per Gram Regulatory Class: I Product Code: LYY Dated: November 24, 1998 Received: December 1, 1998
Dear Mr. Ramalingam:
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 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 Devices: General regulation (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
1
Page 2 - Mr. Ramalingam
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,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement: 3.0
| Applicant: | Contract Latex Dippers Sdn Bhd |
|---|---|
| 510(k) Number: | K983568 |
| Ostar D'Pro Latex Examination Glove ८ १०० سومس جمع کے | |
| Device Name: | of TataTwarer extractable Profess |
| Indications for Use: | per gram ; Powderex |
The Ostar D'Pro glove is a disposable patient examination The Ostal D ITO glove the hand of healthcare and similar personnel 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
Stavett for Chiu Len
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices 510(k) Number H98.35 68