(63 days)
Not Found
Not Found
No
The device description and intended use clearly define it as a disposable examination glove, with no mention of AI or ML capabilities.
No
The device, an examination glove, is used to prevent contamination and is not intended for treating or alleviating a disease or condition.
No
The device is described as a glove worn on the hand to prevent contamination, which is a barrier function, not a diagnostic one.
No
The device description clearly states it is a physical examination glove, which is a hardware device, not software.
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 contamination between healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description is for a glove, a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT."
Product codes
LYY
Device Description
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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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
HEALTH CARE 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
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.)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 1999
Mr. Ang Teck Leong Managing Director SSN Gloves (M) Sdn. Bhd. Lot 147, Jalan Selvadural, Off Jalan Ipoh, 51200 Kuala Lumpur, MALAYSIA
K990526 Re: Kleenhands Powder-Free Latex Examination Trade Name: Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: February 12, 1999 February 19, 1999 Received:
Dear Mr. Ang Teck Leong:
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 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 The general controls provisions of the Act 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. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ang Teck Leong
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" (21 CFR 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/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 Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string begins with the capital letter 'K', followed by the numbers '990526'. The handwriting is in a simple, clear style, making the characters easily readable. The image appears to be a close-up of the handwritten string.
3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling the louise the 1000mission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
8
| SSN GLOVES (M) SDN. BHD.
| Applicant: ___________________________________________________________________________________________________________________________________________________________________ | ||
|---|---|---|
| 510(k) Number (if known): __ N / A = | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Device Name: ................................................................................................................................................................. Indications For Use: CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE : DEVICE WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Chim S. hin
ivision Sign-Off) Division of Dental. Infection Control. and General Hospital D 510(k) Number
Prescription Use Per 21 CFR 801.109
OR
Over-The-Counter X
- For a new submission, do NOT fill in the 510(k) number blank.
(Optional Formsi 1-2-96)