(111 days)
No
The summary describes a standard examination glove and does not mention any AI or ML capabilities.
No
This device, Powder-Free Blue Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment.
No
Explanation: The device is described as a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." Its function is barrier protection, not the diagnosis of a disease or condition.
No
The device description and performance studies clearly indicate a physical, disposable glove made of nitrile, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and standards met for examination gloves. There is no mention of any components or functions related to analyzing samples from the human body.
- Lack of Diagnostic Elements: There are no mentions of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical integrity, safety, and barrier properties of the gloves, not on diagnostic accuracy or performance.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
Product codes
LZA
Device Description
The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purpose
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 device was evaluated against ASTM D6319-10 standards for dimensions, physical properties, freedom from pinholes (AQL 2.5), and powder-free status (
§ 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
K12/528
33278 Central Ave., #102 Union City, CA 94587, USA T. 510.429.8692 F. 510.487.5347 TOLL FREE.1.888.988.8788
510(k) Summary
1.0 Submitter/ 510(k) Owner:
Name: Address: Shen Wei USA Inc. 33278 Central Ave. Suite 102 Union City, CA. 94587
Phone No: 510-429-8692 Fax No: 510-487-5347
Manufacturer:
Name: ZHANGJIAGANG JIAMEI RUBBER PRODUCTS CO., LTD Address: FENGHUANG TOWN, ZHANGJIAGANG CITY, CHINA 215614
Phone No: 520-845-0023 Fax No: 520-845-0311
Date 510k Summary was prepared: August 7th, 2012
2.0 Contact Person:
| Name: | Albert Li |
|---|---|
| Phone No: | 510-429-8692 |
| Fax No: | 510-487-5347 |
3.0 Name of the device:
| Trade Name: | Powder-Free Blue Nitrile Examination Gloves Peppermint
Scented |
|----------------------|-------------------------------------------------------------------|
| Device Name: | Powder-Free Blue Nitrile Examination Gloves Peppermint
Scented |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient examination glove (21 CFR 880.6250, Product
Code FMC) |
| Product Code: | Nitrile -80LZA |
Predicate Device Information: 4.0
Image /page/0/Picture/16 description: The image shows a logo for Shen Wei USA Inc. The logo features a black hand above the company name, with the words "PROMOTING YOUR SUCCESS!" underneath. The website address, www.shenweiusa.com, is also included at the bottom of the logo.
SEP 11 2012
1
The predicate device is K090194, Powder-Free Nitrile Examination Gloves, Black Color, 07/07/2009. Class I Powder Free Nitrile Examination gloves, 80LZA, that meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20.
Description of The Device: 5.0
The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile.
6.0 Labeling and Intended Use of the Device:
Draft labels for Powder-Free Blue Nitrile Examination Gloves Peppermint Scented, can be found in Attachment 3.
The Powder-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Indication for Use Statement can be found in Attachment 4.
7.0 Summary of the Technological Characteristics of the Device
The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented, are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from pinholes | ASTM D6319-10 | |
| FDA 21 CFR 800.20 | Meets, AQL 2.5 | |
| Powder-Free | ASTM D 6124-06 | Meets |