(16 days)
Not Found
No
The device is a standard medical glove and the summary contains no mention of AI or ML technology.
No
The intended use states the device is worn to prevent contamination, which is a barrier function, not a therapeutic action.
No
The device is described as examination gloves, intended to prevent contamination between patient and examiner, and is not designed to diagnose any condition.
No
The device is a physical glove, not software. The description focuses on material properties and physical standards.
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 the body) to diagnose a condition.
- Device Description: The description focuses on the physical properties and standards met by the glove, 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 (proteins, genes, pathogens, etc.)
- Providing diagnostic information about a patient's health status.
- Regulatory Classification: Patient examination gloves are typically classified under a different regulatory category than IVDs (e.g., Class I or Class II medical devices).
The information provided strongly indicates that this device is a standard medical glove used for barrier protection, not an IVD.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Light 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests concluded that the Powder Free Vinyl Patient Examination Gloves, Light Yellow Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, and meet labeling claims.
Clinical data is not needed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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)
DEC - 4 2009
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: " (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 Jaysun Glove Co.,Ltd. | |
|---|---|---|
| Submitter's address : | No.199 Jiangling Avenue, Suqian Economic | |
| Development Zone,Suqian 223800, Jiangsu,China | ||
| Phone number : | 86-527-84568809 | |
| Fax number : | 86-527-84568806 | |
| Name of contact person: | Ms.Sea Xu | |
| Date the summary was prepared: | Oct.30, 2009 |
[(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 Color | |
|-------------------------|-------------------------------------------------------------------------------------------------------|--|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves,
Light 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 | |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
1
Class I* Powder Free Vinyl Patient Examination Gloves, Light Yellow Color that mee the requirements of ASTM standard D 5250-06e1.
Predicate device: Powder-Free Vinyl Patient Examination Gloves, JIANGSU JAYSUN GLOVE CO., LTD., K062522 .
[(a)(4)] A description of the device
Device Description : Powder Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder Free Vinyl Patient Examination Gloves, Light 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Vinyl Patient Examination Gloves, Light 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 |