(87 days)
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Not Found
No
The device description and intended use clearly define a standard examination glove, with no mention of AI/ML capabilities or related technologies.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, primarily for protective and hygienic purposes, not to treat or cure a disease or condition.
No
The device is described as a "patient examination glove," which is used to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device description clearly states it is a physical glove, which is a hardware component. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "disposable device intended for manuations . or er es that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier for protection during examination, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description is for a "POLYMER COATED, CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING". This is a description of a physical product, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or analytical methods
- Measurement of analytes
Therefore, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for manuations . or er es that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
POLYMER COATED, CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)
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 or finger
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)
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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.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three legs.
MAY 1 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shun Thai Rubber Gloves Industry Public Company Limited C/O Ms. Janna P. Tucker Official Correspondents Tucker Associates 198 Avenue De La D' emerald Sparks, Nevada 89434-9550
Re: K040406
Trade/Device Name: Polymer Coated Chlorinated, Powder-Free Latex Examination Gloves with Protein Labeling (50 ug/g or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 7, 2004 Received: May 10, 2004
Dear Ms. Tucker:
We have reviewed your Section 510(k) promarket 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 - Ms. Tucker
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 Act of all , I outs 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 and insting (2) 21 regulation the quality systems (QS) regulation (21 CFR Part 820); and if requirents as 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), please contact the Office of 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 may oveant 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,
Chiu Lin, Ph.D.
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
Indications for Use
Applicant: SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC COMPANY LIMITED
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
POLYMER COATED, CHLORINATED Device Name: POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)
Indications For Use: A patient examination glove is a disposable device intended for manuations . or er es that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use x (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kai Mulvey
esthesi
510(k) Number.
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