(120 days)
Not Found
No
The device description and intended use clearly describe a standard examination glove with added coatings and scents. There is no mention of any computational or analytical functions that would involve AI or ML.
No
The device, "Latex Examination Gloves," is intended to prevent contamination and is classified as a Patient Examination Glove (per 21 CFR 880.6251), which is not a therapeutic device.
No
The device is described as a disposable glove intended to prevent contamination between patient and examiner, and its performance studies relate to biocompatibility, protein content, and physical properties, not diagnosis.
No
The device description clearly identifies the device as "Latex Examination Gloves," which are physical hardware. The summary discusses physical properties, biocompatibility, and protein content, all related to the material and construction of the gloves, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The device is classified as a "Patient Examination Glove" under 21 CFR 880.6251, which is a classification for general hospital and personal use devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on biocompatibility, protein content, and physical properties relevant to a glove's function as a barrier.
Therefore, this device is a medical device, specifically a patient examination glove, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F
and with Protein Labelian Claim (Combined Citrus-Peppermint), 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 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
Trade and Proprietary Name: Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2.
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
medical purposes / 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)
Physical Properties test and Biocompatibility test.
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
JAN 2 5 2006
SUMMARY PREMARKET 510(k) NOTIFICATION
Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim.
510(k) Number (if known): K052666
Submission Applicant/Official Correspondent:
Jarilyn Lim, President Ascend Eagle Inc. 140-B, Dodd Court American Canyon, CA 94503 707-648-1526 Tel: Fax: 707-648-1534
Submitted: September 26, 2005
Description of the Device:
Trade and Proprietary Name: Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2. Predicative Devices: Latex Powder-Free Examination Gloves
Intended Use of the Device:
These patient examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.
Substantial Equivalence:
Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by US companies. It is Substantially Equivalent to the devices manufactured by SGMP Co., LTD, except by coating, K032293, and by N.S. Uni-Gloves Sdn. Bhd., except by scent, K013163.
Summary of Technological Characteristics:
Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove Quality Assurance: In compliance with ASTM D3578-01a, EN 455-1: 2000, EN 455-2: 2000, EN 455-3: 2000, ISO 2859-1:1999 and manufactured under ISO 9001:2000.
1
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) |
| Palm Thickness: | 0.13 to 0.18 mm (at center of palm) |
| Finger Thickness: | 0.15 to 0.20 mm (at 15mm from tip of center finger) |
| Cuff Thickness: | 0.10 to 0.15 mm (at 40mm from the beaded end) |
BEFORE AGING
Tensile Strength: 21. Mpa minimum Ultimate Elongation:700% minimum Pinhole AQL 1.5 minimum
AFTER AGING
16.0 Mpa minimum 500% minimum 1.5 minimum
Biocompatibility:
The biocompatibility test results are as per attached in Appendix B1 and B2 and show that the gloves passed the tests for examination gloves.
Residual Protein Level:
The extractable protein content test result is a per attached in Appendix B5 and show that the gloves meets the protein labeling claim level at