(106 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related technologies.
No
This device is a patient examination glove, intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is described as a non-sterile disposable glove intended to prevent contamination, which is a barrier function, not a diagnostic one. It does not perform any tests or analyses to identify diseases or conditions.
No
The device is a physical product (gloves) and the summary describes physical properties and testing, not software functionality.
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 physical barrier used during patient examination, not a device used to examine specimens from the human body in vitro (outside the body).
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D 5250-06e1), which are relevant to a physical barrier device.
- 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 those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The device described is a Class I medical device (specifically, a patient examination glove) used for barrier protection during medical examinations.
N/A
Intended Use / Indications for Use
Powdered 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 (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device meets the following standards:
- Dimension: ASTM standard D 5250-06 el.
- Physical Properties: ASTM standard D 5250-06 el.
- Freedom from pinholes: 21 CFR 800.20
- Powder Amount: ASTM standard D 5250-06 el and D6124-06 (
§ 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
Section C 510(k) Summary (21 CFR 807.92)
JUL 2 1 2011
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: K) 10970 " (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | PPP Medical and Safety Products Company Limited |
|---|---|
| Submitter's address : | Xinlian,Houqiao Town, Wuxi,Jiangsu,214106,China |
| Phone number : | 0086-510-88725378 |
| Fax number : | 0086-510-88725378 |
| Name of contact person: | Mr. Zou Xiaojun |
| Date the summary was prepared: | Feb.9, 2011 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powdered Vinyl Patient Examination Gloves,
Clear (non-colored) |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| Proprietary/Trade name: | Powdered Vinyl Patient Examination Gloves,
Clear (non-colored)
Other clients private labeling |
| 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 |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
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Powdered Vinyl Patient Examination Gloves. Predicate device: Clear(Non-colored) , ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. K091662.
[(a)(4)] A description of the device
Device Description: Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powdered 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powdered 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 Amount | ASTM standard D 5250-06 el | |
| and D6124-06 | Meets |