(45 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related technologies.
No
The device, "powder free vinyl patient examination glove," is designed to prevent contamination, not to provide therapy or treat a medical condition. It's a barrier device for examination purposes.
No
The device is a glove for examination purposes, not for diagnosing a condition. It prevents contamination between the patient and examiner.
No
The device is a physical glove, not software. The description clearly states it is a "powder free vinyl patient examination glove" and mentions physical testing standards (ASTM, ISO, 21 CFR).
Based on the provided information, 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 test performed on samples taken from the body.
- Device Description: The description is of a physical barrier (a glove) that meets specific material and performance standards (ASTM D 5250-00-4).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Any form of in vitro testing
The device is clearly described as a patient examination glove, which is a Class I medical device intended for barrier protection during medical examinations.
N/A
Intended Use / Indications for Use
Powder free vinyl 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.
Product codes
LYZ
Device Description
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
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
Nonclinical testing demonstrated that the device meets requirements per ASTM D5250-00-4, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10. Clinical data was not needed. The device performs as well as or better than the legally marketed predicate device.
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
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: K 0 70076 " (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | JIANGSU CUREGUARD GLOVE CO., LTD. |
|---|---|
| Submitter's address : | NO. 205 JIANLING ROAD, THE ECONOMIC |
| DEVELOPMENT ZONE OF SUQIAN CITY, JIANGSU | |
| 223800 CHINA | |
| Phone number : | (86) 0527-4568102 |
| Fax number : | (86) 0527-4568100 |
| Name of contact person: | Mr. Zhang Bohoo |
| Date the summary was prepared: | Jan.02.2007 |
{(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) | |
|---|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves | |
| Other clients private labeling | ||
| Common Name: | Patient examination glove | |
| Classification Name: | Patient examination glove | |
| Device Classification: | I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Panel: | General Hospital (80) | |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* powder free vinyl patient examination gloves , Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0004.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
1
Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
{{a)(5)} The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00c4 | Meets |
| and D6124-01 |