(14 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related computational technologies.
No
The device, a patient examination glove, is intended for barrier protection to prevent contamination, not to treat or therapeutically affect a disease or condition in a patient.
No
Explanation: This device is a patient examination glove used to prevent contamination, not to diagnose a medical condition.
No
The device is a physical glove, not software. The description clearly states it is a "powder free vinyl patient examination glove" and references physical standards like ASTM D 5250-0004.
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 taken from the body.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D 5250-0004). There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Lack of IVD Indicators: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
The device is clearly described as a patient examination glove, which is a Class I medical device used for barrier protection.
N/A
Intended Use / Indications for Use
"Powder free vinyl patient examination glove, white(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."
Product codes
LYZ
Device Description
"powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004"
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)
"Powder free vinyl patient examination gloves , white(non-colored) meet requirements per ASTM D5250-004, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10."
"It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims ."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Freedom from pinholes: "Meets" 21 CFR 800.20
Powder Residual: "
§ 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
C 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."
." (applicant leave blank) "The assigned 510(k) number is:
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 : | HEBEI MANFUL IMPORT & EXPORT CO., LTD | |
|---|---|---|
| Submitter's address : | NO.58 TONGDA ROAD, JINZHOU CITY, HEBEI | |
| PROVINCE, 052260, P.R.CHINA | ||
| Phone number : | (86) 311-4338239 | |
| Fax number : | (86) 311-4338239 | |
| Name of contact person: | Ms. Yanchai Zhang | |
| Date the summary was prepared: | 06 April 2005 |
[(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: | Powder Free Vinyl Patient Examination Gloves, white(non-colored) | |
|---|---|---|
| Proprietary/Trade name: | Powder Free 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 substantial equivalence .
Class I* powder free vinyl patient examination gloves , white(non-colored) that mecels all of the requirements of ASTM standard D 5250-00-4.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
Device Description : powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004
1
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, white(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 powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00c4 | Meets |
| Biocompatability | and D6124-01 |