(16 days)
Not Found
No
The device description and performance studies focus on the physical properties and standards compliance of examination gloves, with no mention of AI or ML.
No
The device is a glove intended to prevent contamination, not to treat or cure a disease or condition.
No
Rationale: The device is a "Powdered Vinyl Patient Examination Glove" intended to prevent contamination between patient and examiner. It does not perform any diagnostic function such as identifying, monitoring, or treating disease. Its purpose is protective.
No
The device is a physical glove made of PVC material, not software. The description clearly outlines its material and physical properties, and the performance studies focus on physical and biocompatibility testing.
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 during physical examination, not a device used to examine specimens from the human body.
- Device Description: The description reinforces the intended use as a barrier worn on the hand or finger.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens 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
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) 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
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
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Section C 510(k) Summary (21 CFR 807.92)
113195
NOV 1 6 2011
.
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:
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 | 2011-10-23 |
| Device Name: | Powdered Vinyl Patient Examination Gloves, Clear (non-colored) |
| Proprietary/Trade name: | Powdered Vinyl Patient Examination Gloves, Clear (non-colored) |
| Common Name: | Other clients private labeling |
| 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* Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM D 5250-06 e1.
Predicate device: Powdered Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091662.
Device Description: Powdered Vinyl Patient Examination Gloves, Clear (non-colored) 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.
Section C
1
Device Intended Use(Indication for use): Powdered 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 Powdered 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 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 | Meets |