(17 days)
Not Found
No
The device is a simple examination glove and the description contains no mention of AI or ML.
No
The device, POWDER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR, is described as preventing contamination between patient and examiner and is worn on the hand or finger. It does not exert any direct therapeutic action or treatment on a disease or condition.
No
The device is described as "Powder Free Vinyl Patient Examination Gloves," which are intended to prevent contamination between patient and examiner. There is no indication that these gloves are used to detect, diagnose, or monitor any medical 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The description clearly states that these gloves are "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device used on the body (the examiner's hand) and during interaction with a patient.
- Intended Use: The intended use is to prevent contamination, not to analyze a specimen for diagnostic purposes.
Therefore, based on the provided information, these gloves are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Yellow Color 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 (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Powder Free Vinyl Patient Examination Gloves, Yellow 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 (medical purposes)
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 performance was evaluated against 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
Section C 510(k) Summary (21 CFR 807.92)
NOV 1 7 2011
:
KI 3 9
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: | Powder Free Vinyl Patient Examination Gloves, |
| Yellow Color | |
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves, |
| Yellow 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, Yellow Color that meets all of the requirements of ASTM D 5250-06 e1.
网站_365bet官网_365bet官网官网 狗万体育 Predicate device: Powder-Free Vinyl Patient Examination Glove, Yellow Color, PPP; i Medical and Safety Products Limited. K110972.
Device Description: Powder Free Vinyl Patient Examination Gloves, Yellow 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 Viny) Patient Examination Gloves, Yellow 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, Yellow 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 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 |