(232 days)
Not Found
No
The device is a disposable examination glove, and the description and performance studies focus on material properties and regulatory standards, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or alleviate a disease or condition.
No
Explanation: The device is a glove intended to prevent contamination, not to diagnose a condition.
No
The device is a physical product (gloves) made of poly(vinyl chloride) polymer compound, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function for protection, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the barrier function and mentions the material (poly(vinyl chloride)). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The device is a medical device, specifically a patient examination glove, but its function is protective and preventative, not diagnostic.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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
LYZ
Device Description
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) are disposable devices which made of poly(vinyl chloride) polymer compound, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between pattent and examiner and they meets all of the requirements of ASTM standard D 5250-06 el .
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
Not Found
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
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) meet requirements per ASTM D5250-06e1, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10:2002/Amd1:2006.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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: (110016 ."
Premarket Notification [510(k)] Summary
| Submitter's name : | RONGYAO PLASTIC PRODUCE CO., LTD |
|---|---|
| Submitter's address : | #58 BINHU ROAD, HENGSHUI CITY, 053000,CHINA |
| Phone number : | (86) 318-2126583 |
| Fax number : | (86) 318-2126588 |
| Name of contact person: | Mr. Zhao Gang |
| Date the summary was prepared: | Jul. 25, 11 |
| Device Name: | Powder free Vinyl Patient Examination Gloves, Colored |
| (Yellow) | |
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
Class I* powder free vinyl patient examination gloves , colored (yellow) that meets all of the requirements of ASTM standard D 5250-06e1.
Predicate device : Powder free Vinyl Patient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .
Device Description:Powder free Vinyl Patient Examination Gloves, Colored (Yellow) are disposable devices which made of poly(vinyl chloride) polymer compound, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between pattent and examiner and they meets all of the requirements of ASTM standard D 5250-06 el .
Device Intended Use(Indication for use ): Powder free Vinyl Patient Examination Gloves, Colored (Yellow) 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 summary of the technological characteristics of new device compared to the predicate device.
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
1
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06e1. | Meets |
| Physical Properties | ASTM standard D 5250-06e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06e1 | |
| and D6124-01 | Meets |