(54 days)
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No
The summary describes a standard medical glove and contains no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No
This device, a sterile nitrile examination glove, is intended to prevent contamination between patient and examiner, not to treat or alleviate a medical condition.
No
Explanation: The device is described as a glove intended to prevent contamination between patient and examiner, which is a barrier function, not a diagnostic one. It does not gather information about the patient's health condition.
No
The device is a physical glove, not software. The description clearly states it is a "Sterile Nitrile Examination Glove".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to be worn on the examiner's hand to prevent contamination. It does not involve testing or analyzing any biological samples.
- The description clearly states it's a glove for medical purposes. Gloves are considered medical devices, but not IVDs.
The information provided aligns with the description of a standard medical glove, which falls under a different regulatory category than IVDs.
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
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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
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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)
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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
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2002
Mr. Ng Yew Soon Executive Director Smart Glove Corporation Sdn Bhd Lot 6487 Batu 5 3/4 Sementa, Jalan Kapar, Selangor Darul Ehsan, MALAYSIA 42100
Re: K021013
Trade/Device Name: Smart Glove Sterile Nitrile Examination Goves Powder free Regulation Number: 880.6250 Regulation Name: Examination gloves Regulatory Class: I Product Code: LZA Dated: March 25, 2002 Received: March 29, 2002
Dear Mr. Soon:
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.
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. . . . . . .
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. You must comply with 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
Enclosure
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Image /page/2/Picture/0 description: The image shows the words "SMART GLOVE CORPORATION SDN. BHD." in bold, black letters. The words "SMART GLOVE" are larger than the rest of the text. The words "CORPORATION SDN. BHD." are smaller and to the right of the words "SMART GLOVE".
Company No. 403570-D page 3 of 4 5
Indication for Use Statement: 3.0
INDICATION FOR USE
Applicant: SMART GLOVE CORPORATION SDN. BHD.
K021013 Applied for 510(k) Number:
Sterile Nitrile Examination Gloves (Powdered Free) Device Name:
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 OR Over-The-Counter (Optional Format 1-2-96)
Qhin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Lot 6487, Batu 5 3/4 , Sementa, Jalan Kapar, 42100 Klang, Selangor Darul Ehsan, Malaysia. Tel: KΩ3-32016100 Fav: KΩ3-32017526 / OR96 / 270017747
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