(170 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No.
The device is a glove intended to prevent contamination between a patient and an examiner, which is a barrier function, not a therapeutic action.
No
The document describes a nitrile examination glove, which is a barrier device for preventing contamination, not a diagnostic tool used for identifying medical conditions.
No
The device description clearly states it is a "Nitrile powder-free patient examination glove," which is a physical hardware device. The performance studies also focus on physical properties like waterleak tests.
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 physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (nitrile), form (powder-free), and compliance with standards related to physical properties and safety for examination gloves.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Nitrile powder-free 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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
Nitrile powder-free patient examination, that meets all of the requirements of ASTM standard D 6319-00ae3.
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)
The nitrile powder-free patient examination glove, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 6319-00ae3. | Meets |
| Physical Properties | ASTM standard D 6319-00ae3. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6124-01 | 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
AUG = 8 2003
C 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 "
applicant leave blank) "The assigned 510(k) number is:
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 : | JDA (TIANJIN) PLASTIC RUBBER CO., LTD. |
|---|---|
| Submitter's address : | 17 HAIBIN 7 RD. TIANJIN TREE TRADE ZONE, |
| TIANJIN ,300456,P.R.China | |
| Phone number : | (86)22-25760468 |
| Fax number : | (86)22-25760466 |
| Name of contact person: | Wan Dong Hua, Technology Department Manager |
| Date the summary was prepared: | 23 May 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 | Nitrile powder-free patient examination glove |
|---|---|
| Proprietary/Trade name: | LEGEND™ Nitrile powder-free patient examination glove |
| Common Name: | Other clients private labeling |
| Patient examination glove | |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |
(a)(3)). An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Nitrile powder-free patient examination, that meets all of the requirements of ASTM standard D 6319-00ae3.
Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. K993247 .
|(a)(4)| A description of the device
1
Device Description : Nitrile powder-free patient examination, that meets all of the requirements of ASTM standard D 6319-00ae3.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Nitrile powder-free 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The nitrile powder-free patient examination glove, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 6319-00ae3. | Meets |
| Physical Properties | ASTM standard D 6319-00ae3. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6124-01 | Meets |