(252 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, "Latex Examination Gloves," is intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It does not treat or cure a disease or condition.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove, not a software application. The description focuses on material properties and physical tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiners hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description is for examination gloves, which are a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies mentioned (Biocompatibility, Residual Powder, Physical Property, Water Tight Test) are related to the physical integrity and safety of the glove as a barrier, not its ability to diagnose a 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 glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner. The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim.
Material: Latex
Cuff: Beaded
Powder Residue: Maximum 2mg/glove
In compliance with ASTM D3578-10, ISO 2859-1:1999, Quality Assurance: manufactured under ISO9001:2000 and ISO 13485
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Thickness: .08mm minimum
BEFORE AGING: Tensile Strength: 18.0. Mpa minimum; Ultimate Elongation: 650% minimum
AFTER AGING: 14.0 Mpa minimum; 500% minimum
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XS — XL
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim meets the physical property requirements of ASTM D 3578-10, the FDA 1000 ml water test both before and after aging, and the 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.
0
MAR 2 1 2012
SUMMARY PREMARKET 510(k) NO.TIFICATION Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim
Submission Applicant -
UG Healthcare (USA) Inc 1565 Sunflower Avenue Costa Mesa, Ca. 92626
Official Correspondent -
Kenneth J. Stanton 1565 Sunflower Avenue Costa Mesa, Ca 92626 Tel: (714)444-2248 Fax: (714)444-2271
Submitted: July 7, 2011
Description of the Device: Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim
Trade Name: Various
Common Name: Examination Gloves A. Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-10. Predicative Devices: Latex Powder-Free Examination Gloves
Intended Use of the Device: 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 the patient and the examiner.
SUMMARY PREMARKET 510(k) NOTIFICATION for - Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim
Page - 9
1
K 112005
Summary of Technological Characteristics:
Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove In compliance with ASTM D3578-10, ISO 2859-1:1999, Quality Assurance: manufactured under ISO9001:2000 and ISO 13485
Inspection Parameters:
| Criteria | Inspection Level | AQL |
|---|---|---|
| Dimensions | S-2 | 4.0 |
| Physical Properties | S-2 | 4.0 |
| Water Tight Test 1000ml | G-1 | 1.5 |
| Visual Major Defects | G-1 | 1.5 |
| Visual Minor Defects | G-1 | 2.5 |
Physical Properties:
| Dimensions: | |
|---|---|
| Overall Length: | 240 mm minimum |
| Width: | 95 mm minimum (for medium glove) |
| Thickness: | .08mm minimum |
BEFORE AGING
Tensile Strength: 18.0. Mpa minimum Ultimate Elongation:650% minimum
AFTER AGING
14.0 Mpa minimum 500% minimum
Special Properties: None
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XS — XL
Conclusion: The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim meets the physical property requirements of ASTM D 3578-10, the FDA 1000 ml water test both before and after aging, and the Protein Labeling Claim Level at