(395 days)
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No
The device is a patient examination glove, and the summary describes standard performance testing for gloves (water tightness, biocompatibility, powder content, protein level). There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a protective function rather than a therapeutic one (treating or alleviating a disease or condition).
No
The device is a patient examination glove, which is intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device is a physical patient examination glove, not a software-only medical device. The description and performance studies focus on the physical properties and performance of the glove.
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 hand or finger. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: It's described as a Class I latex patient examination glove. This classification and description align with a medical device used for protection, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the physical integrity and composition of the glove (water tightness, powder content, protein level), which are relevant to its barrier function and safety, not its diagnostic capability.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.
A 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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01ar2 Standard Specification for Latex Examination Gloves for Medical' Application.
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
health care 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)
Water Tight Test: Using the FDA specified 1,000 ml water leak test, 1.25 pieces of each size of the gloves were tested.
UN-AGED:
X-Small: Sample Size 125, Leaked 1
Small: Sample Size 125, Leaked 0
Medium: Sample Size 125, Leaked 1
Large: Sample Size 125, Leaked 2
AGED:
X-Small: Sample Size 125, Leaked 0
Small: Sample Size 125, Leaked 1
Medium: Sample Size 125, Leaked 2
Large: Sample Size 125, Leaked 1
The above figures are within the FDA/ASTM D3578-01aE2 requirements for latex exam gloves of 2.5% AQL.
Biocompatibility: The bio-compatibility test results are as per Appendix M which shows that the gloves passed the tests in question.
Total Residual Powder Content & Presence of Cornstarch:
Residual Powder Content (ASTM D 6124-01): Range: 0.5-0.8mg/glove, Mean: 0.63 mg/glove (FDA INTERNAL REQUIREMENT: 2 mg/glove max)
Presence of Cornstarch: Negative (FDA INTERNAL REQUIREMENT: Negative)
Residual Protein Level:
Protein labeling claim level at
§ 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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with the head facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2003
SGMP Company Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' emerald Sparks, Nevada 89434-9550
Re: K023537
Trade/Device Name: Non-Sterile Powder Free Green Latex Patient Examination Gloves with Nopal/Aloe Vera/Vitamin E and Donning Aid Coating, and With Protein Labeling Claim (