(297 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No
The device is a glove intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device, Powder Free Vinyl Patient Examination Gloves, is described as a non-sterile disposable device for preventing contamination between patient and examiner. Its intended use and description do not mention any diagnostic functions, but rather state that it is worn on the examiner's hand to prevent contamination.
No
The device is a physical glove made of PVC material, not software. The description explicitly states it is a disposable device worn on the hand or finger.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function for protection, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the barrier function, stating it's made of PVC and worn on the hand or finger for contamination prevention.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical properties, freedom from pinholes, powder residual, and biocompatibility – all related to the glove's function as a protective barrier. There are no studies related to diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purpose 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, Clear (non-colored) are disposable devices which made of PVC material , intended for medical purpose that worn on examiner's hand or linger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
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's
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 nonclinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06(Reapproved 2011). | Meets |
| Physical Properties | ASTM standard D 5250-06(Reapproved 2011). | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011). and D6124-06(Reapproved 2011). | Meets |
§ 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)
510(K) Summary
"This summary of 510(k) safety and cffectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: K130101 11
Premarket Notification [5]0(k)] Summary
NOV 08 2013
| Submitter's name : | Bytech Dongtai Co.,Ltd. |
|---|---|
| Submitter's address : | Xing Yuan Industrial Park, Tang Yang Town, Dong Tai City, JiangSu, 224200 China |
| Phone number : | 0086-515-85655500 |
| Fax number : | 0086-515-85655500 |
| Name of contact person: | Mr. Wang Cheng |
| Date the summary was prepared: | 2013-09-29 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Proprietary/Trade name: | "Bytech" |
| 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 |
Class I* Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM D 5250-06 (Reapproved 2011).
Predicate device: Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.
Device Description: Powder Free Viny| 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 linger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
' Section C (rev.01)
1
Device Intended Use (Indication for use): Powder Free Viny) 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(Reapproved 2011). | Meets | |
| Physical Properties | ASTM standard D | |
| 5250-06(Reapproved 2011). | Meets | |
| Freedom from | ||
| pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | |
| (Reapproved 2011). | ||
| and D6124-06(Reapproved 2011). | Meets |