(64 days)
No
The 510(k) summary describes a standard medical glove and provides performance data based on physical and biocompatibility testing, with no mention of AI/ML technology or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models.
No.
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
The device is a glove for preventing contamination, not for diagnosing a medical condition.
No
The device is a physical glove, not software. The description focuses on material properties and physical performance standards.
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: It's a glove, a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical properties, freedom from pinholes, powder residue, and biocompatibility – all related to the glove's function as a barrier and its safety for contact with skin. There are no studies related to diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not fit that description.
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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were conducted to demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device. The tests included: Dimension, Physical Properties, Freedom from pinholes, Powder Residual, and Biocompatibility. The results showed that the device meets ASTM standard D 5250-00e4, ASTM D6124-01, 21 CFR 800.20, and ISO10993-10 requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Dimension: Meets ASTM standard D 5250-00e4.
- Physical Properties: Meets ASTM standard D. 5250-00e4.
- Freedom from pinholes: Meets 21 CFR 800.20
- Powder Residual:
§ 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
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."
NOV 2 0 2003
"The assigned 510(k) number is: 032908 ." (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 : | Shijiazhuang Fuguan Plastic Products Co., Ltd. | |
|---|---|---|
| Submitter's address : | The Jia Village, Dahe County, Lu Quan City, Hebei Province, | |
| 050204 P.R.China | ||
| Phone number : | (86) 311 229 4202 | |
| Fax number : | (86) 311 229 1575 | |
| Name of contact person: | Chun-jing AN | |
| Date the summary was prepared: | 12 September 2003 |
[(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, white(non-colored) | |
|---|---|---|
| Proprietary/Trade name: | FUGUAN (Brand) 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 , white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.
Predicate device : synthetic powder-free (white ) vinyl patient examination glove, Shijiazhuang Great Eagle Plastics Products Co., Ltd. K000071 .
[(a)(4)] A description of the device
1
Device Description : powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, white(nonis a disposable device intended for medical purposes that is worn on the examiner's colored) 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 5250-00e4. | Meets |
| Physical Properties | ASTM standard D. 5250-00e4. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 | Meets |
| Biocompatability |