(336 days)
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 technology.
No
The device is described as a non-sterile disposable glove intended to prevent contamination between the patient and examiner, primarily functioning as a barrier. It does not provide any therapeutic effect or treatment.
No
The device, "Powder Free Vinyl Patient Examination Gloves," is intended for medical purposes to prevent contamination between patient and examiner by forming a barrier. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove made of PVC film, designed to be worn on the hand or finger. It describes material properties and manufacturing standards for a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical procedures.
- Device Description: The description focuses on the physical properties of the glove (PVC film, barrier to body fluids, tensile properties) and its manufacturing standards (ASTM). It does not mention any components or functions related to testing or analyzing samples from the human body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This glove does not perform any such analysis.
- Performance Studies: The performance studies focus on the physical and barrier properties of the glove, not on the accuracy or reliability of diagnostic results.
Therefore, based on the provided information, this device is a medical device used 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) is a non-sterile 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
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. Its 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 glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 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 / Not Specified
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 meets per requirements per ASTM D5250-06 (Reapproved 2011), ASTM CFR 800.20 10993-10: D6124-06 (Reapproved 2011), per 21 and ISO 2002/Amd. 1:2006.
Key results from comparison to ASTM or equivalent standard:
- Dimension: Meets ASTM standard D 5250-06 (Reapproved 2011).
- Physical Properties: Meets ASTM standard D 5250-06 (Reapproved 2011).
- Freedom from pinholes: Meets 21 CFR 800.20.
- Powder Residual: Meets ASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reapproved 2011),
§ 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:_______________________________________________________________________________________________________________________________________________ 그
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Heze City Green Food Co.,Ltd. |
|---|---|
| Submitter's address : | Jinzhuang Zone, Suji Caoxian, Heze |
| City,Shandong, 274415 China | |
| Phone number : | 0086-530-5022111 |
| Fax number : | 0086-530-5311988 |
| Name of contact person: | Mr.Jerry Zhang |
Date of preparation: 2014-01-23
Name of the Device 2.0
| Device Name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) |
|-------------------------|----------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | 1 |
| 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:
- How the device functions: 4.1 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. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
Section C(rev.03)
1
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 glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 | |
| Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (9/13)