(35 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No.
The device (gloves) is intended to prevent contamination between the patient and examiner, primarily for protection, not for treating any specific medical condition or restoring health.
No
The device is described as a glove intended to prevent contamination, not to diagnose any condition. The "Summary of Performance Studies" focuses on physical properties and biocompatibility, not diagnostic accuracy.
No
The device is a physical glove, not software. The description clearly states it is a "disposable device intended for medical purposes that is worn on the examiner's hand or finger".
No, 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 barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties and standards met by the glove, not on any diagnostic capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any information about a patient's health status based on testing in vitro.
- Performance Studies: The performance studies focus on physical properties, freedom from pinholes, powder residual, and biocompatibility – all related to the glove's function as a barrier and its safety for use on the skin. There are no studies related to diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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)
LYZ
Device Description
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
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
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)
The device meets the following standards:
- Dimension: ASTM standard D 5250-06 el. (Meets)
- Physical Properties: ASTM standard D 5250-06 el. (Meets)
- Freedom from pinholes: 21 CFR 800.20 (Meets)
- Powder Residual: ASTM standard D 5250-06 el and D6124-06 (Meets,
§ 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
510(K) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: Kill 75C " (applicant leave blank)
Premarket Notification [510(k)] Summary
| Submitter's name : | Shandong jianhong new material company |
|---|---|
| Submitter's address : | Xisha, Guoli Town, Huantai County, Zibo City, Shandong Province, 255000,China |
| Phone number : | 0086-533-8437998 |
| Fax number : | 0086-533-8437998 |
| Name of contact person: | Mr.Tian Jianguo |
| Date the summary was prepared: | May 10, 2011 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Other clients private labeling |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
Class I* Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Predicate device: Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored), ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. K091663.
Device Description: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
1
Device Intended Use (indication for use): Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 el. | Meets |
| Physical Properties | ASTM standard D 5250-06 el. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 el | |
| and D6124-06 | Meets |