(252 days)
No
The device description and performance studies focus on the physical properties and material characteristics of examination gloves, with no mention of AI or ML.
No
The device, a nitrile examination glove, is intended for preventing contamination between patient and examiner, not for treating or diagnosing any medical condition.
No
The device is a glove worn to prevent contamination, not to diagnose a condition or disease.
No
The device is a physical product (gloves) and the description focuses on material properties, physical dimensions, and performance tests related to those physical characteristics. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiners hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed on a sample taken from the body.
- Device Description: The description reinforces the use as a barrier on the hand or finger.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
- Performance Studies: The performance studies focus on physical properties, water tightness, and biocompatibility – characteristics relevant to a barrier device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. 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.
Indications for Use - Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue
Cuff: Beaded Material: Nitrile
Powder Residue: Maximum 2mg/glove
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue meets the physical property requirements of ASTM D 6319-10, 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
SUMMARY PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue
MAR_2 1 2012
Submission Applicant: UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa. Ca. 92626
Official Correspondent: Kenneth J. Stanton,President UG Healthcare (USA) Inc. 1565 Sunflower Avnue Costa Mesa, Ca 92626 . Tel: (714)444-2248 Fax: (714)444-2271
Trade Name: Non-Sterile, Description of the Device Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue
- A. Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class 2: Powder-Free Nitrile examination glove 80LZA that meets all of the requirements of ASTM D6319-10. *Predicative Devices: Nitrile 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.
1
SUMMARY PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Glove Blue
Summary of Technological Characteristics:
Cuff: Beaded Material: Nitrile
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003
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: |
| Width: |
| Thickness: |
240 mm minimum 95 mm minimum (for medium glove) .05 mm minimum
BEFORE AGING
AFTER AGING
Tensile Strength: 14.0. Mpa minimum Ultimate Elongation:500% minimum
14.0 Mpa minimum 400% minimum
Special Properties: None
Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case
Sizes: XS — XL
Conclusion: Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue meets the physical property requirements of ASTM D 6319-10, the FDA 1000 ml water test both before and after aging, and the Protein Labeling Claim Level at