(42 days)
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No
The summary describes a standard examination glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device description and intended use clearly state that the glove is for preventing contamination, which is a barrier function, not a therapeutic one. It does not treat or cure any medical condition.
No
The device, a Powder-Free Latex Examination Glove, is intended to prevent contamination and is not used to diagnose a medical condition or disease.
No
The device description clearly states it is a "Powder-Free Latex Examination Glove," which is a physical hardware device. There is no mention of software as the primary or sole component.
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 healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The device is a glove, which is a physical barrier.
- Lack of Diagnostic Elements: There is no mention of any components or functions related to analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information.
- No Mention of IVD-Related Activities: The description doesn't involve any processes typically associated with IVDs, such as sample collection, preparation, analysis, or interpretation of results for diagnostic purposes.
The device is clearly intended for personal protective equipment (PPE) and infection control, not for diagnosing a disease or condition.
N/A
Intended Use / Indications for Use
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Product codes
LYY
Device Description
Powder-Free Latex Examination Glove with Protein Labeling Claim ( 50 Micrograms or Less )
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
healthcare worker and similar personnel
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
AY 1 4 2002
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Mr.Tan Swu Choon Syntex Healthcare Products Company Limited No. 1 Fanjiazhung Industrial Zone Xinii City, Hebei Province, P. R. CHINA 052360
Re: K021059
Trade/Device Name: Powder-Free Latex Examination Glove with Protein Labeling Claim ( 50 Micrograms or Less ) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: March 20, 2002 Received: April 2, 2002
Dear Mr. Choon:
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
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,
Susan Runes
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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K 021059 510(K) Number (if known): _
Powder-Free Latex Examinat Device Name WITH PROTEIN LABELING
Indication For Use :
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Atyhr Clen
inn Sian-(Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -----------
| Prescription Use: | |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over The Counter Use | |
| (Optional Format 1-2-95) |