(11 days)
Powder free vinyl 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.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.
The provided text describes a submission for a medical device, specifically "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)," rather than a complex AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not applicable as they relate to studies of diagnostic accuracy, which are not performed for basic medical devices like gloves.
Here's an analysis based on the provided text for the aspects that are applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 & D6124-01 | <2mg/glove |
| Biocompatibility: | ||
| - Primary Skin Irritation | ISO10993-10 | Passes (Not a Primary Skin Irritation) |
| - Dermal Sensitization | ISO10993-10 | Passes (Not a Dermal Sensitization) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the document for each test. The standards referenced (e.g., ASTM D5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10) specify sampling plans for testing, but the exact number of gloves tested for this specific submission is not provided.
- Data Provenance: Not explicitly stated. The testing was conducted by the manufacturer, JIANGSU JAYSUN GLOVE CO., LTD, which is based in China. The data would therefore be internal testing results generated by the manufacturer. It is prospective testing, as it's performed to demonstrate compliance of the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. This device is a physical product (gloves), and performance is assessed against engineering standards and biocompatibility tests, not by expert interpretation or diagnosis for which "ground truth" established by human experts would be relevant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study requiring adjudication of expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the referenced International and National Standards (e.g., ASTM D 5250-00e4 for physical properties, 21 CFR 800.20 for freedom from pinholes, ASTM D6124-01 for powder residual, and ISO10993-10 for biocompatibility).
8. The sample size for the training set:
Not applicable. This device does not involve machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established:
Not applicable. This device does not involve machine learning algorithms.
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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: K OG 252 2(applicant leave blank)
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 : | JIANGSU JAYSUN GLOVE CO., LTD |
|---|---|
| Submitter's address : | NO. 199 JIANLING AVENUE, SUQIAN ECONOMIC DEVELOPMENTZONE, SUQIAN CITY, JIANGSU PROVINCE, 223800, CHINA |
| Phone number : | (86)527-4568809 |
| Fax number : | (86)527-4568806 |
| Name of contact person: | Ms. Sea XU |
| Date the summary was prepared: | Aug. 20,2006 |
((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, Clear (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 , Clear(non-colored) that meets 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
: 10 : 10 : 10 : 10 : 10 : 1
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Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, Clear(non-colored) is a Device intended Ester powate not wall 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 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 | Meets |
| Biocompatability | and D6124-01Primary Skin Irritation inrabbits | <2mg/glovePassesNot a Primary Skin Irritation |
| Dermal sensitization in theguinea pig | PassesNot a Dermal sensitization |
((b)(1) A brief discussion of the nonclinical submitted, reference, or relied on in the ((0)(1) A brief diseason ission for a determination of substantial equivalence .
Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-0064, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.
{(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket ((0)(2)) { }) { } }) { } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } }
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
((b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a){3).
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 .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's mission and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jiangsu Javsun Glove Company, Limited C/O Ms. Chu Xiaoan Beijing Easy-Link Company Room 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Beijing, China 100083
SEP - 8 2006
Re: K062522
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Regulatory Class: I Product Code: LYZ Dated: August 20, 2006 Received: August 28, 2006
Dear Ms. Xiaoan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Page 2 - Ms. Xiaoan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Devicc Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: JIANGSU JAYSUN GLOVE CO., LTD
510(k) Number (if known): *
Device Name:_Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored)
Indications For Use:
Powder free vinyl 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule H. Murphy, KS 9/8/16
nesthesiology, General Hospil.al, ontrol, Dental Devices
) Number: K012522
§ 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.