(51 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is a glove intended to prevent contamination, not to treat a medical condition or disease.
No
Explanation: The device, a powdered vinyl patient examination glove, is intended to prevent contamination and is not described as being used to identify or analyze medical conditions or diseases.
No
The device is a physical product (gloves) and does not involve any software component.
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 physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the material (powdered vinyl) and adherence to standards related to gloves (ASTM D 5250-06).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies mentioned relate to the physical properties and safety of the glove (meeting ASTM standards, biocompatibility), not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Powdered vinyl 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.
Product codes
LYZ
Device Description
powdered vinyl patient examination gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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)
The submission states Powdered vinyl patient examination gloves, Clear (Non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87 ANSI / ISO 10993-10:2002.
They meet:
- Dimension per ASTM standard D 5250-06
- Physical Properties per ASTM standard D 5250-06
- Freedom from pinholes per 21 CFR 800.20
- Powder Amount per ASTM standard D 5250-06 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
Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance and
ess of the submit of SMDA, 1990 and 21 CFR 807.92." "This summary of 510(k) sately and chool.veness.
with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________
JUL 80 2009
Premarket Notification [510(k)] Summary
દ
ﻬﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
Premarket Notinention (on the first page, preferably on your letterhead paper, the ((a)(1)). The summary contains on the first page, preferably on your tetections the submitter states the submitter the summary was prepared : VIJAN PLASTIC PRODUCTS
| Submitter's name : | ZHANGJIAGANG FENGYUAN PLASTIC PRODUCTS
CO.,LTD | |
|--------------------------------|-----------------------------------------------------------------------|--|
| Submitter's address : | Hengjing Village Tangqiao Town Zhang Jia Gang
Jiangsu,215615,China | |
| Phone number : | (86) 512-68416802 | |
| Fax number : | (86) 512-68416685 | |
| Name of contact person: | Mr. Yu Bang Ting | |
| Date the summary was prepared: | May.26.2009 | |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the contribution in [(a)(2)]. The name of the device, Including the classification name, if known
| Device Name: | Powdered Vinyl Patient Examination Gloves, Clear (Non-
colored) |
|-------------------------|-----------------------------------------------------------------------------|
| Proprietary/Trade name: | Powdered Vinyl Patient Examination Gloves
Other clients private labeling |
| 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 |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming
. The success of the substantial equivalence .
Sillstantal varied villant examination gloves, Clear (Non-colored) that meets all of the 11
1 the supported a capaced D 5250-06 Class I' powdered viny pundard D 5250-06.
requirents of ASTASTAL Powdered Vinyl Patient Examination Gloves, Shijiazhuang
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang
Pre Predicate device : 1 OGGTIF (C. . Fuguan Plastic Products Co., Ltd.. K032907.
[(a)(4)] A description of the device
Device Description : powdered vinyl patient examination gloves, Clear (Non-colored) that meets
(1) = 1) = 1 = 1 = = = = $ ASTM standard D $250-06. Device Description . powdered vary .
all of the requirements of ASTM standard D 5250-06.
1
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered viny] patient examination glove, Clear (Nonis a disposable device intended for medical puposes that is worn on the examiner's and colored) is a disposable device intended for mealor patient and examiner.
hand or finger to prevent contamination between patient and examiner.
Thand or finger to prevent con
[(a)(6)] A summary of the technological characteristics of new device compared to the f
ell comment predicate device.
promotered virus.
The powdered the following technological characteristics compared to The powdered vinyl patient examination gloves, Clear Nortorers, and of the powered to
are summarized with the following technological characteristics compared to
lare summari ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 | |
| and D6124-06 |