(147 days)
No
The device is a disposable glove with a color change and a citric acid coating. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device, a disposable glove, is intended to prevent contamination between patient and examiner, and is not designed to treat, cure, mitigate, or prevent disease or affect the structure or function of the body.
No
Explanation: The device is a glove for preventing contamination and does not perform any diagnostic function.
No
The device is a physical glove, not software. The description details material properties and physical characteristics, not software functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for infection control, not a device used to examine specimens from the human body.
- Device Description: The description focuses on the physical properties and composition of a glove, not on any components or functionalities related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in those specimens
- Providing information for diagnosis, monitoring, or treatment based on specimen analysis.
This device falls under the category of a medical device used for personal protection and infection control.
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 Nitrile Examination Gloves, Orange is substantial equivalent to Powder-Free Nitrile Examination Gloves, Black Color with 510k number K090194 that is currently marketed. The device modification is a change in color from Black to Orange. Another device modification is the addition of adding a citric acid coating to the interior surface of the gloves to achieve a pH of 5.0 - 5.5 for the inner surface of the glove.
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 Powder-Free Nitrile Examination Gloves, Orange Color are summarized with the following technological characteristics compared to ASTM or equivalent standards:
- Dimensions: Meets ASTM D6319-10
- Physical Properties: Meets ASTM D6319-10
- Freedom from pinholes: Meets ASTM D6319-10, AQL 2.5 and FDA 21 CFR 800.20
- Powder-Free: Meets ASTM D 6124-06 (
§ 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
120890
Image /page/0/Picture/1 description: The image shows a logo for ShenWei USA Inc. The logo features a stylized black hand above the text "ShenWei usa inc." The text is in a bold, sans-serif font, with "ShenWei" being larger than "usa inc."
Shen Wei USA Inc. 33278 Central Ave. Suite 102 Union City, CA.94587
510(k) Summary
AUG 1 7 2012
1.0 Submitter:
Name: Shen Wei USA Inc. Address: 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: 220-842-03 I 1
Date 510k Summary was prepared: July 8th, 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 Nitrile Examination Gloves, Orange Color |
|---|---|
| Device Name: | Powder-Free Nitrile Examination Gloves, Orange Color |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient examination glove (21 CFR 880.6250, Product Code FMC) |
| Product Code: | Nitrile-80LZA |
4.0 Predicate Device Information:
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.
1
0
5.0 Description of the Device Modification:
The Powder-Free Nitrile Examination Gloves, Orange is substantial equivalent to Powder-Free Nitrile Examination Gloves, Black Color with 510k number K090194 that is currently marketed. The device modification is a change in color from Black to Orange. Another device modification is the addition of adding a citric acid coating to the interior surface of the gloves to achieve a pH of 5.0 - 5.5 for the inner surface of the glove.
6.0 Labeling and Intended Use of the Device:
Draft labels for Powder-Free Nitrile Examination Gloves, Orange can be found in Attachment 1. The only change to labeling is before it was labeled black glove and now the present labels being labeled orange glove and added "(@) pH 5.0-5.5".
The Powder-Free Nitrile Examination Gloves, Orange 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 2.
7.0 Summary of the Technological Characteristics of the Device
The Powder-Free Nitrile Examination Gloves, Orange Color 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 | Meets, AQL 2.5 |
| FDA 21 CFR 800.20 | ||
| Powder-Free | ASTM D 6124-06 | Meets |