(366 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.
No
The device, a latex examination glove, is intended to prevent contamination between patient and examiner, serving as a barrier rather than directly treating or mitigating a disease or condition.
No
Explanation: The device is described as a glove intended to prevent contamination, not to diagnose medical conditions or provide information for diagnosis. Its performance studies focus on physical properties and safety, not diagnostic accuracy.
No
The device is a physical glove, not software. The description clearly indicates it is a disposable device worn on the hand.
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.
- Device Description: The description confirms it's a glove with specific coatings and claims, again, related to its barrier and protective properties.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on physical properties, water tightness, and protein levels – all related to the glove's integrity and safety as a barrier, not its ability to diagnose.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This glove does not perform any such tests.
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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim
KIII604
JUN - 8 200
Submission Applicant -
UG Global Resources Sdn Bhd 181 Floor No. 18 Jalan Dato' Abd Rahman 70000 Seremban Malaysia
Official Correspondent -
Kenneth J. Stanton 1565 Sunflower Avenue Costa Mesa, Ca 92626 Tel: (714)444-2248 Fax: (714)444-2271
Submitted: November 16, 2011
Description of the Device: Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim
Trade Name: Lano-E
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.
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1
SUMMARY PREMARKET 510(k) NOTIFICATION for - Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim
1011604
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: Lanolin and Vitamin E inner coating
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 with Lanolin and Vitamin E Coating, 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