(84 days)
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No
The summary describes a standard medical glove and contains no mention of AI or ML technology.
No
The device, a sterile latex examination glove, is intended for preventing contamination between a patient and an examiner. It does not provide any therapeutic benefit or treatment to the patient.
No
Explanation: The device is a glove for preventing contamination and is not described as having any diagnostic function.
No
The device description clearly states it is a physical glove, not software.
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 glove is for preventing contamination between patient and examiner by being worn on the hand. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description is for a sterile latex examination glove, which is a medical device used for protection, not for diagnosing a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological specimens, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not fit that description.
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
LYY
Device Description
Sterile Latex Examination Gloves (Powdered) with protein claim less than 100 µg/g
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
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Indicated Patient Age Range
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Intended User / Care Setting
Examiner / Medical purpose
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.)
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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.
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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.
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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).
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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/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Foo Khon Pu Managing Director Smart Glove Corporation Sdn. Bhd Lot 6487 Batu 5 3/4 Jalan Kapar Klang Selangor, MALAYSIA
NOV 1 6 2001
Re: K012856
Trade/Device Name: Sterile Examination Gloves (Powdered) with Protein Claim 100 Micrograms or Less Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: August 13, 2001 Received: August 24, 2001
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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can 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
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Fet of all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements 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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/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 Radiological Health
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RPORATION SDN. BHD.Page 3 or
Company No. 403570-D
3.0 Indication for Use Statement:
| NOV 1 6 2001 | INDICATION FOR USE |
|---|---|
| -------------- | -------------------- |
| Applicant: | SMART GLOVE CORPORATION SDN. BHD. |
|---|---|
| 510(k) Number: | Applied for K012856 |
| Device Name: | Sterile Latex Examination Gloves (Powdered) with protein claim less than 100 µg/g |
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)
OR
Olin S. Lin
Division Sign-Off)
Vision of Dental, Infection Cont Ceneral Hospital De Number
Prescription Use Per 21 CFR 801.109 Over-The-Counter (Optional Format 1-2-96)
Lot 6487, Batu 5 3/4 , Sementa, Jalan Kapar, 42100 Klang, Selangor Darul Ehsan, Malaysia. Tel: 603-3916100 Fax: 603-3917526 / 9826 / 3903762 Website for medical gloves: www.smartglovecorp.com.my likholto for alorinion alounc ununer alongentiald one mu
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