(46 days)
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No
The device is a simple examination glove and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
The device, a patient examination glove, is described as preventing contamination between patient and examiner, not as treating or curing a disease or condition.
No
Explanation: The device is a glove intended to prevent contamination, not to diagnose any condition. Its purpose is protective, not diagnostic.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a glove worn on the hand or finger to prevent contamination between the patient and examiner. It acts as a physical barrier.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test.
The device is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
Powder 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 (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Powder 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested against ASTM standard D 5250-06 el (Dimension, Physical Properties), 21 CFR 800.20 (Freedom from pinholes), ASTM standard D 5250-06 el and D6124-06 (Powder Residual), ISO 10993-10 (Biocompatibility - Primary Skin Irritation in rabbits, Dermal sensitization in the guinea pig). All tests showed the device meets the respective standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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: (13193 "
Premarket Notification [510(k)] Summary
| Submitter's name : | Suqian Ruijiang Medical Supplies Co., Ltd. | |
|---|---|---|
| Submitter's address : | No.119 Hongzhehu Road, Suqian, Jiangsu, | |
| 223800, China | ||
| Phone number : | 86-527-84391929 | |
| Fax number : | 86-527-84391929 | |
| Name of contact person: | Mr.Donmei Yu | |
| Date the summary was prepared: | 2011-10-23 | |
| Device Name: | Powder Free Vinyl Patient Examination Gloves, | |
| Clear (non-colored) | ||
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves, | |
| Clear (non-colored) | ||
| Common Name: | Other clients private labeling | |
| Exam gloves | ||
| 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, 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: Powder 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.
Section C
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Device Intended Use(Indication for use): Powder 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 Powder 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 |