(196 days)
No
The device is a simple disposable glove and the summary contains no mention of AI or ML.
No.
The device (gloves) is intended to prevent contamination, which is a diagnostic/preventative function, not a therapeutic one.
No
The device is a non-sterile disposable glove worn on the hand or finger to prevent contamination, not to diagnose a condition.
No
The device is a physical glove made of PVC material, not software.
No, 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 examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens in vitro (outside of the body).
- Device Description: The description reinforces the intended use, stating it's a "disposable device which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner."
- Lack of IVD Characteristics: The description and performance data focus on physical properties, freedom from pinholes, powder residual, and biocompatibility – characteristics relevant to a protective barrier device. There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or other conditions. This device is a physical barrier for protection during patient contact.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, White Color 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
LYZ
Device Description
Powder Free Vinyl Patient Examination Gloves,White Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
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
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 performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
The Powder Free Vinyl Patient Examination Gloves, White Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
Dimension: ASTM standard D 5250-06 e1. Meets
Physical Properties: ASTM standard D 5250-06 e1. Meets
Freedom from pinholes: 21 CFR 800.20. Meets
Powder Residual: ASTM standard D 5250-06 e1 and D6124-06.
§ 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
Section C 510(k) Summary (21 CFR 807.92)
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: 1( ( 1 ) 3 ) 94 "
Premarket Notification [510(k)] Summary
| Submitter's name : | Suqian Ruijiang Medical Supplies Co., Ltd. |
|---|---|
| Submitter's address : | No.119 Hongzhehu Road, Suqian, Jiangsu, 223800, China |
| Phone number : | 86-527-84391929 |
| Fax number : | 86-527-84391929 |
| Name of contact person: | Mr.Donmei Yu |
| Date the summary was prepared: | 2012-03-28 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves, White Color |
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves, White Color 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, White Color that meets all of the requirements of ASTM D 5250-06 e1.
Predicate device: Powder-Free Vinyl Patient Examination Glove, White Color Tangshan Henda Plastic Products Co., Ltd. K102558.
Device Description: Powder Free Vinyl Patient Examination Gloves,White Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
1
Device Intended Use(Indication for use): Powder Free Vinyl Patient Examination Gloves, White Color 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, White Color, 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 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 | |
| and D6124-06 |