(29 days)
No
The device description and intended use clearly define the device as a disposable examination glove made of PVC, with no mention of any computational or analytical capabilities that would involve AI or ML.
No
Explanation: The device, Powdered Free Vinyl Patient Examination Gloves, is described as preventing contamination between patient and examiner. It is not intended for diagnosis, treatment, or prevention of disease, which are typically functions of a therapeutic device.
No
Gloves are used to prevent contamination, not to diagnose a medical condition or disease.
No
The device description clearly states it is made of PVC material and is a physical glove, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the material (PVC) and its function as a barrier. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Keywords: The document does not contain keywords typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "reagent," "sample," "analyte," etc.
- Performance Studies: The performance studies mentioned are non-clinical tests supporting substantial equivalence, not clinical studies evaluating the accuracy of a diagnostic test.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a physical barrier used during examination, not a tool for analyzing biological samples.
N/A
Intended Use / Indications for Use
Powdered 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
Powdered 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 e1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
The conclusions
It can be concluded that the Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.
It can be concluded that the Powdered Free Vinyl Patient Examination Gloves, Clear is as safe, as effective, and performs as well as the predicate device, (non-colored) Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
MAR - 6 2012
Section C 510(k) Summary (21 CFR 807.92)
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: 4203588
Premarket Notification [510(k)] Summary
| Submitter's name : | Hongxin Plastic Products Co.,Ltd. |
|---|---|
| Submitter's address : | No. 899-1 Hengtong Road, Zhoucun, Zibo, Shandong,255300 China |
| Phone number : | 0086-13831119188 |
| Fax number : | 0086-311-84316178 |
| Name of contact person: | Mr.Guan Zhenfeng |
| Date the summary was prepared: | 2012-01-23 |
| Device Name: | Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Proprietary/Trade name: | Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored). |
| Common Name: | Other clients private labeling. Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | 1 |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
Class I* Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM D 5250-06 e1.
Predicate device: Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.
Device Description: Powdered 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 e1.
1
Device Intended Use (Indication for use): Powdered 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.
A summary of the technological characteristics of new device compared to the predicate device.
The Powdered 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 el. | Meets |
| Physical Properties | ASTM standard D 5250-06 el. | Meets |
| Freedom | ||
| from | ||
| pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 el | |
| and D6124-06 | Meets |