(177 days)
Not Found
No
The document describes a standard medical glove and makes no mention of AI or ML technology.
No.
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to provide therapeutic benefit.
No
Explanation: The device, a powdered vinyl patient examination glove, is intended for preventing contamination between patient and examiner during medical procedures. It does not perform any diagnostic function.
No
The device is a physical glove made of polyvinyl chloride and cornstarch powder, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens from the human body in vitro (outside the body).
- Device Description: The description focuses on the material (polyvinyl chloride), the presence of powder (cornstarch), and compliance with standards related to physical properties and barrier function. There is no mention of reagents, assays, or any components used for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or treatment based on specimen analysis.
The device is a medical device, specifically a patient examination glove, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The powdered vinyl patient examination glove, 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. The powder is made from cornstarch. It is color free and is sold as non sterile.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Powdered vinyl patient examination gloves, clear (non-colored) are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. The powder is made from cornstarch. The gloves are color free.
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 (medical purposes)
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)
Tests were conducted following the recommended procedures outlined in the respective consensus standards.
Key results:
- Dimension: Meets ASTM D5250-06
- Physical Property: Meets ASTM D5250-06
- Free of Pinhole: Meets ASTM D5151-06
- Residue Powder: Meets ASTM 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
JAN 3 1 2013
Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification
Wealth On (Jiangsu) Co., Ltd Dongyuan Village, Hengji Town, Jianhu County Yancheng, Jiangsu Province, China Tel: 86- 21-33517339 Submitter's FDA Registration Number: 3009307502
US Agent and Contact Person
Charles Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: June, 2012
Device Name: Proprietary Name:
Common Name: Classification Name: Device Classification: Regulation Number: Panel: General Product Code:
Powdered Vinyl Patient Examination Glove, Clear (noncolored) (or other clients private labeling) Patient examination glove Patient examination glove I 21 CFR 880.6250 Hospital LYZ
Predicate Device Information:
- (1) K081657, "Powdered Vinyl Patient Examination Gloves, Light Yellow", manufactured by "Jiangsu Cureguard Glove Co., Ltd. "
- (2) K110219, "Powder Free Vinyl Patient Examination Gloves", manufactured by "Wealth on (Jiangsu) Co., Ltd. (our own company). "
Device description:
Powdered vinyl patient examination gloves, clear (non-colored) are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D
1
5250-06, except for sterility requirements. The powder is made from cornstarch. The gloves are color free.
Indications for Use:
The powdered vinyl patient examination glove, 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. The powder is made from cornstarch. It is color free and is sold as non sterile.
Comparison to Predicate Devices
The powdered vinyl patient examination gloves, clear (non-colored), non sterile are compared with the following Predicate Devices in terms of in terms of these three areas: Indications for Use/Design/Material, Performance, and Labeling.
- (1) K081657, "Powdered Vinyl Patient Examination Gloves, Light Yellow", manufactured by "Jiangsu Cureguard Glove Co., Ltd."
- (2) K110219, "Powder Free Vinyl Patient Examination Gloves", manufactured by "Wealth on (Jiangsu) Co., Ltd. (our own company)." ·
Substantial equivalence is established with respect to intended use, Labeling, performance, design, materials, and other applicable characteristics. Side-by-side comparison tables that include the following four areas are provided below:
- Indication for Use A:
- Labeling (labels, instructions for use, promotional material) for the legally B: marketed device to which substantial equivalence is claimed.
- Performance data supporting substantial equivalence C:
- Design and materials D:
- Indications for Use: A:
The following table shows similarities and differences in indications for use between our device and the predicate devices.
| Description | Our Device | Predicate Device 1 (K081657) | Predicate Device 2 (K110219) |
|---|---|---|---|
| Indication | |||
| for Use | Disposable device intended for | ||
| medical purposes that is worn on | |||
| the examiner's hand or finger to | |||
| prevent contamination between | |||
| patient and examiner. The powder | |||
| is made from cornstarch. | Disposable device intended for | ||
| medical purposes that is worn | |||
| on the examiner's hand or | |||
| finger to prevent contamination | |||
| between patient and examiner. | Disposable device intended for | ||
| medical purposes that is worn on | |||
| the examiner's hand or finger to | |||
| prevent contamination between | |||
| patient and examiner. The powder | |||
| is Powder free |
Table 5.1: Comparison of Indications for Use
Our device and K081657, K110219 are almost identical in terms of indications for use. The only difference is that our device uses cornstarch as the powder source, while the
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powder source for K081657 is not specified. This minor difference is not significant enough to alter how and when the gloves should be used.
Our device and K110219 are also almost identical in terms of indications for use. The only difference is that K110219 is powder free while this device is powdered with cornstarch as the powder source. This minor difference is not significant enough to alter how and when the gloves should be used.
B: Labeling:
The labels for both our device and predicate device are provided in Section 13 of this submission (Sec13.1 and 13.2 for our device, Sec13.3 for the predicate device K081657, and Sec 11.4 for K110219).
The following table shows similarities and differences of key elements of the labeling between our device and the predicate devices.
| Description | Our Device | Predicate Device 1
(K081657) | Predicate Device 2
(K110219) |
|-------------------------------------------|-------------------------------------------|------------------------------------------|----------------------------------------------|
| Product Name | Yes (Powered Vinyl
Examination Gloves) | Yes (Cureguard Gloves
Vinyl Powdered) | Yes (Power Free Vinyl
Examination Gloves) |
| Manufacturer Name
and Address | Yes | No | Yes |
| Product Model,
Size, and Lot
Number | Yes | Yes | Yes |
| Quantity/Box | Yes | Yes | Yes |
| Color Statement | Yes | Yes | Yes |
| Storage
Recommendation | Yes | No | Yes |
| Single Use
Statement | Yes | Yes | Yes |
| Sterility Statement | Yes | Yes | Yes |
Table 5.2: Comparison of Key Elements in Labeling
The label for this device under submission is identical to K110219, except for this device is labeled as Powdered, while K110219 is labeled as powder free.
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The label for this device under submission is very similar to K081657. Actually it contains all the information the K081657 label has, and more.
C: Performance:
The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for powdered Vinyl Patient Examination Gloves, Clear (non-colored) (or other clients private labeling), manufactured by "Wealth On (Jiangsu) Gloves Co., Ltd" met all relevant requirements in the test standards, and are comparable to the predicate device.
Table 5.3: Comparison of Physical, Biocompatibility and Performance Testing
| Description | Our Device | Predicate Device 1
(K081657) | Predicate Device 2
(K110219) |
|----------------------------------------------|------------------------------------|------------------------------------|----------------------------------------------|
| Dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06