(45 days)
Not Found
Not Found
No
The summary describes a standard examination glove and contains no mention of AI or ML technology.
No.
The device is a glove for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose any condition.
No
The device is a physical glove, not software. The description clearly states it is a "Powder Free Nitrile Examination Glove".
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 patient and examiner by being worn on the examiner's hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a glove, which is a physical barrier.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information about a patient's health status
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's hand
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 Department of Health & Human Services - USA. 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 graphic of three horizontal lines, each slightly curved and stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 2004
Mr. Foo Khon Pu Managing Director Smart Glove Corporation SDN.BHD. Lot 6487, Batu 534, Sementa, Jalan Kapar, 42100 Klang, Selangor Darul Ehsan MALAYSIA
Re: K033683
Trade/Device Name: Smart-Glove Powder Free Nitrile Examination Gloves Pink Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: October 7, 2003 Received: November 24, 2003
Dear Mr. Pu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), it has be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Pu
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements modified in the Federal statutes and regulations administered by other Federal agencies. or the Free of any - each all the Act's requirements, including, but not limited to: registration 1 od intilisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and inomis (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rins reter notification. The FDA finding of substantial equivalence of your device to a promarket notification 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), 11 you deems specific as a Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrls/dsma/dsmamain.html
Sincercly yours,
Clis
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
CORPORATION SDN. BHD
Company No. 403570-D
Page 3 of 42
Indication for Use Statement: 3.0
INDICATION FOR USE
| Applicant: | SMART GLOVE CORPORATION SDN. BHD. |
|---|---|
| 510(k) Number: Applied for | K033683 |
| Device Name: | SMART-FEEL Powder Free Nitrile Examination Gloves (Pink Color) |
Indication For Use:
This glove is disposable and intended for medical purpose that is worn on the examiner's hand 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
Over-The-Counter ਾਕ
Over-The-Counter
(Optional Format 1-2-96)
Jilruen Dr. Halers, Senile Chef
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Numbe
Image /page/2/Picture/16 description: The image shows three different certification logos. The first logo is a diamond shape with the words "QUALITY SYSTEM" inside. The second logo is a square shape with a crown and a checkmark, and the letters "UKAS" below. The third logo is a trapezoid shape with the letters "TUV" inside.