(84 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard medical glove, with no mention of AI/ML or related technologies.
No.
The device description and intended use indicate it is an examination glove for preventing contamination, not for treating a disease or condition.
No
The device is a glove, intended for preventing contamination, not for diagnosing medical conditions.
No
The device 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 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: It's a sterile examination glove. This is a medical device used for protection and hygiene, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This glove does not perform such a 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 provide a barrier between patient and examiner.
Product codes
LZA
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
hand
Indicated Patient Age Range
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Intended User / Care Setting
examiner
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): 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.
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Image /page/0/Picture/1 description: The image shows the 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Mr. Ng Yew Soon Executive Director Smart Glove Corporation Sdn. Bhd Lot 6487 Batu 5 3/4 Jalan Kapar Klang Selangor, MALAYSIA
Re: K012853
Trade/Device Name: Smart Glove Sterile Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not
1
Page 2 - Mr. Soon
mean that FDA has made a determination that your device complies with other requirements mean that FDA has made a decernmance and regulations administered by other Federal agencies. of the Act or ally Federal statutes and regulations, but not limited to: registration You must comply with an the Act 3 requirements interest and manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CrK I all 607), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act);
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 This letter will allow you to begill marketing your substantial equivalence of your device to
510(k) premarket notification. The FDA finding of substantial equivalence and th 510(K) premarket nouncedion: "The 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 If you desire specific advice for your for itrovitro diagnostic devices), please contact the and additionally 21 CFR Far 807176 108. Additionally, for questions on the promotion and Office of Comphance at (301) 591 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 6 - - - 6 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - advertising of your avvise, promoted, "Misbranding by reference to premarket Also, piease note the regulation entitled on your responsibilities under notification (ZTCFK Part 007.97): Oaks general Manufacturers, International and the Act may be oblained from the Driller of School of (301) 443-6597 or at its Consumer Assistance at to ton efda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Ti A. Ulatowski
Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Company No. 403570-D
RPORATION SDN. BHD
Indication for Use Statement: 3.0
INDICATION FOR USE NOV 1 6 2001
| Applicant: | SMART GLOVE CORPORATION SDN. BHD. |
|---|---|
| 510(k) Number: Applied for | K012853 |
| Device Name: | Sterile Nitrile Examination Gloves (Powdered) |
Indication For Use:
This glove is disposable and intended for medical purpose that is worn on the examiner's This glove is disposition 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)
Qlin S, Lin
OR
Over-The-Counter
(Optional Format 1-2-96)
(Division Sign-Off) Consion of Dental, Infection Control, a General Hospital Devi Cafely Number
Prescription Use Per 21 CFR 801.109
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
Image /page/2/Picture/12 description: The image contains two logos related to quality systems. The first logo on the left features a diamond shape with the words "QUALITY SYSTEM" inside an oval at the top, and the letters "CIDIM" at the bottom. The second logo on the right has a crown above a check mark, with the letters "UKAS" and the words "QUALITY MANAGEMENT" below it. Both logos are black and white and appear to be related to quality assurance or certification.