(106 days)
No
The device is a glove and the description focuses on material properties and standards compliance, with no mention of AI/ML.
No.
The device is described as a glove intended to prevent contamination, not to treat or alleviate a disease or condition. Its purpose is protective, not therapeutic.
No
The device description clearly states it is for "medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This indicates its function is protective rather than diagnostic.
No
The device description clearly states it is a disposable device worn on the hand, and the performance studies focus on physical properties and biocompatibility, indicating a physical hardware device (gloves). There is no mention of software components.
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. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details examination gloves, which are a physical barrier.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical properties and safety of the gloves (dimensions, pinholes, protein levels, biocompatibility), not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
Product codes
LYY
Device Description
The Pearlescent Black Textured Powder-Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with (Protein Content Labeling Claim) Contains 50 micrograms or less of Total Water Extractable Protein per gram which had been submitted and cleared under 510(k) number K013793. The difference in this submission is a change of color to be Pearlescent Black.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand (examiner's)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner, medical purpose
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 Pearlescent Black Textured Powder-Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards:
- Dimensions: Meets ASTM D 3578-05e1
- Physical Properties: Meets ASTM D 3578-05e1
- Freedom from pinholes: Meets ASTM D 5151-99 (AQL 2.5)
- Powder Residual: Meets ASTM D 6124-06 (
§ 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
MAY 1 1 2010
K10021/5002
510(k) SUMMARY
1.0 Submitter
ﺎ ﻓ
| Name | Shen Wei (USA) Inc. |
|---|---|
| Street Address | 33278 Central Ave., Suite 102 |
| Union City, CA. 94587 | |
| Phone No. | (510)429-8692 |
| Fax No. | (510)487-5347 |
Date of Summary Prepared: 1/20/2010
2.0 Contact Person:
| Name: | Mr. Albert T Li |
|---|---|
| Phone No. | (510)429-8692 |
| Fax No. | (510)487-5347 |
3.0 Device Identification:
Glove Proprietary or Trade Name: (Multiple Names) Pearlescent Black Textured Powder- Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with Protein Content Labeling Claim (50 micrograms or less) Common Name: Exam gloves
Classification Name: Patient examination glove (per 21 CFR 880.6250) Classification Information: Class I Latex patient examination glove 80LYY, powder-free and meeting all the requirements of ASTM D 3578-05e1 Standard Specification for Latex Examination Gloves for Medical Application.
4.0 Identification of the Legally Marketed Device:
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM D 3578-05e1 Standard Specifications for Latex Examination Gloves for Medical Application.
5.0 Description of the Device:
The Pearlescent Black Textured Powder- Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with (Protein Content Labeling Claim) Contains 50 micrograms or less of Total Water Extractable Protein per gram which had been submitted and cleared under 510(k) number K013793
1
1
The difference in this submission is:
- a) Change of color to be Pearlescent Black. (MSDS Attachment C)
Reference Documents:
ッ
- a) SOP for Random Sampling of pH 5.0-5.5 Gloves to Ensure pH 5.0-5.5 Coating of Gloves (Attachment A)
- b) Testing to Confirm pH 5.0-5.5 of gloves (Attachment B)
- c) Characterization and Application of Aloe Vera at pH 5.0-5.5 (Attachment Four)
The modification of the device does not affect the intended use of the device as well it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections
The Pearlescent Black Textured Powder- Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with Protein Content Labeling Claim meets all the requirements of ASTM D 3578-05e1 Standard Specification for Latex Examination Gloves for Medical Application.
6.0 Intended Use of Device:
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is single use only.
7.0 Summary of Technological Characteristics for Modified Device:
The Pearlescent Black Textured Powder-Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-05e1 | Meets |
| Physical Properties | ASTM D 3578-05e1 | Meets |
| Freedom from pinholes | ASTM D 5151-99 | Meets (AQL 2.5) |
| Powder Residual | ASTM D 6124-06 | Meets ( |