(44 days)
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No
The 510(k) summary describes a standard medical glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML devices.
No
The device, Black Latex Examination Gloves, is intended to prevent contamination between patient and examiner, serving as a barrier. It does not exert any therapeutic action on the body or treat any medical condition.
No
Explanation: The device is described as a glove intended to prevent contamination, not to diagnose medical conditions.
No
The device description clearly states it is a physical product (gloves) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Intended Use: The intended use of these gloves is to prevent contamination between a patient and an examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting specific analytes (proteins, DNA, etc.) in a sample.
- Providing diagnostic information about a patient's health status.
Therefore, the Non-Sterile, Powder-Free, Black Latex Examination Gloves are a medical device, but they fall under the category of a barrier device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water extractable protein per gram of 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.
Product codes
LYY
Device Description
Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water soluble protein per gram of 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 logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle head in profile, facing left. The eagle's head is composed of three parallel, curved lines that suggest feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shun Thai Rubber Gloves Industry Public Company, Limited C/O Ms. Janna P. Tucker Tucker and Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434-9550
Re: K060229
Trade/Device Name: Non-Sterile, Powder Free, Black Latex Exam Gloves with. Protein Labeling Claim (50 micrograms or less of total water soluble protein per gram of glove) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I
MAR 1 5 2006
Product Code: LYY
Dated: January 23, 2006 Received: January 30, 2006
Dear Ms. Tucker:
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 - Ms. Janna P. 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. 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), 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 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 vours.
Suette y. Mchain Orris
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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INDICATIONS FOR USE
APPLICANT: SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 9, M004 Kached Muang Rayong, Thailand 21110
510(k) NUMBER:
DEVICE NAME:
Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water soluble protein per gram of glove)
Indications For Use:
The Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water extractable protein per gram of 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.
Prescription Use ... ... ................ AND/OR Per 21 CFR 801.109
Over-The-Counter Use ... ... ....... (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula W. Murphy, M.D. 3/14/14
Gov. General Hospital
K 066229