(155 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No.
The device is described as a glove intended to prevent contamination, not to treat a disease or condition.
No
The device is a medical glove, designed to be a barrier to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a physical glove made of PVC material, intended to be worn on the hand or finger. It describes physical properties and manufacturing processes related to a tangible product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties of the glove as a barrier to body fluids and bloodborne pathogens. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies listed (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatability) are all related to the physical integrity and safety of the glove as a barrier device, not its ability to perform diagnostic tests on biological samples.
In summary, the device is a medical device intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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)
LYZ
Device Description
PVC films form a barrier to body fluids and bloodborne Pathogens.
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM DS250-06(Reapproved 2011) and ASTM D5151-06(Reapproved 2011) requirements.
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)
Not Found
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
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: _K131826 11
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Jiangsu Toptouch Glove Co., Ltd. |
|---|---|
| Submitter's address : | No.103 Xihu Road, Suqian, Jiangsu, 223800 |
| China | |
| Phone number : | 86-527-88286077 |
| Fax number : | 86-527-88286077 |
| Name of contact person: | Mr.Zhong Miao |
| Date of preparation : | 2013-11-12 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) |
|-------------------------|----------------------------------------------------------------------|
| Proprietary/Trade name: | Toptouch |
| 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 |
3.0 Predicate device
| Device Name: | Powder-Free Vinyl Patient Examination Glove
(Non-colored) |
|----------------|--------------------------------------------------------------|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co.Ltd. |
| 510(K) Number: | K091663. |
4.0 Device Description:
4.1 How the device functions: PVC films form a barrier to body fluids and bloodborne Pathogens
4.2 Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a
1
medical procedure.
Physical and performance characteristics such as design, materials and 4.3 physical properties:
Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM DS250-06(Reapproved 2011) and ASTM D5151-06(Reapproved 2011) requirements.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), 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(Reapproved 2011). | Meets | |
| Physical Properties | ASTM standard D | |
| 5250-06(Reapproved 2011). | Meets | |
| Freedom from | ||
| pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | |
| (Reapproved 2011).and | ||
| D6124-06(Reapproved 2011). | Meets |