(39 days)
Not Found
No
The 510(k) summary describes a standard medical glove and contains no mention of AI, ML, or related technologies.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device is described as a glove intended to prevent contamination, and its performance studies do not mention any diagnostic capabilities or outcomes.
No
The device is a physical glove, not software. The description clearly states it is a "powder free vinyl patient examination glove" and mentions meeting ASTM standards for physical properties.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device used for protection, not a device used to examine specimens in vitro (outside of the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and standards met by the glove (ASTM D 5250-06). This is consistent with a medical device used for protection.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a patient's health status
The device is a medical device, specifically a patient examination glove, but it falls under a different regulatory category than IVDs.
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, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
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
Nonclinical tests were performed. Powder free vinyl patient examination gloves, (Light Yellow) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800,20 and ISO10993-10. It was concluded that the device meets the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, and meets labeling claims. Clinical data was not needed.
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: KO81655 " (applicant leave blank)
21 2008
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: | May.26.2008 |
[(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 ( Light Yellow) |
|---|---|
| Proprietary/Trade name: | Rubber-Like |
| 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 (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : Powder-Free Vinyl Patient Examination Gloves, JIANGSU CUREGUARD GLOVE CO., LTD.. K070076
[(a)(4)} A description of the device
1
Device Description : powder free vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination gloves, (Light Yellow) 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 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | Meets |
| Biocompatability | and D6124-01 |