(78 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 metrics associated with algorithmic analysis.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device, patient examination gloves, is described as preventing contamination between a patient and examiner. It does not perform any diagnostic function such as identifying, assessing, or predicting a medical condition or disease.
No
The device is described as physical examination gloves, which are hardware, 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 hands. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is of a physical glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, 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 compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.
Product codes
LZA
Device Description
Powdered Patient Nitrile Examination Gloves (White/Blue Color)
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
hands or fingers
Indicated Patient Age Range
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Intended User / Care Setting
medical purposes
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 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 a logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three abstract shapes that resemble human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kenny Hoe Kok Seong General Manager HL Rubber Industries Sdn. Bhd. Lot 10, Kawasan Perindustrian Dioh 72000 Kuala Pilah Negeri Sembilan MALAYSIA
8 2007 FEB
Re: K063522
Trade/Device Name: Powdered Patient Nitrile Examination Gloves (White/Blue Color) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 18, 2007 Received: January 22, 2007
Dear Mr. Seong:
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
Page 2 - Mr. Seong
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 modi that 1 DA mas may Federal statutes and regulations administered by other Federal agencies. or the Fet of all , I out a I the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 cost torth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadistion 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) Prins reter notification. The FDA finding of substantial equivalence of your device to a premainer lettribution on 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), rf you desire specific at no at (240) 276-0115. 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 may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Swen Ruppre
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
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Image /page/2/Picture/0 description: The image shows a logo with the letters "HLRI" in a stylized font. The letters are horizontally aligned and have a three-dimensional appearance with a double-lined border. Behind the letters, there are two overlapping oval shapes that create a sense of depth and movement. The logo is black and white, giving it a clean and professional look.
HL RUBBER INDUSTRIES SDN BHD
(621188-H)
INDICATION FOR USE STATEMENT
: HL RUBBER INDUSTRIES SDN BHD Applicant : K063522 510K Number (if known) : Powdered Patient Nitrile Device Name Examination gloves (White / Blue color)
:
Indications for use
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH office of Device Evaluation (ODE)
Shule R. Murphy, MD
1 I
Prescription use Per 21 CFR 801.109 OR
Over-The-Counter