(37 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 5250-0008.
The provided text describes the acceptance criteria and the study for a medical device, specifically "Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)". The study's purpose is to demonstrate substantial equivalence to a predicate device, which is a common pathway for Class I medical devices in the US.
Here's the breakdown of the requested information:
1. Table of acceptance criteria and the 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 and D6124-01 | <2mg/glove |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | Dermal sensitization in the guinea pig | Passes (Not a Dermal Sensitization) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., dimension, physical properties, pinholes). It refers to the standards (ASTM D 5250-00e4, ASTM D6124-01, 21 CFR 800.20, ISO10993-10) which would contain the prescribed sampling plans. The data provenance is not specified beyond being "submitted, reference, or relied on". Given the context of a 510(k) submission from a Chinese manufacturer, the testing likely occurred at facilities approved to conduct tests according to these international standards, but specific country of origin for the data is not mentioned. The study is a non-clinical evaluation, not a retrospective or prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device performance and biocompatibility study, not a study requiring expert clinical judgment to establish ground truth. The "ground truth" is established by adherence to the specified technical standards and regulations.
4. Adjudication method for the test set
Not applicable. As this is a non-clinical performance test, there isn't an "adjudication method" in the sense of reconciling human expert opinions. The results are based on objective measurements and observations according to standardized test protocols.
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 device is a patient examination glove, a Class I medical device. It is not an AI-powered diagnostic or assistive technology, and therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As stated above, this is not an AI algorithm.
7. The type of ground truth used
The "ground truth" in this context is defined by the technical specifications and requirements outlined in recognized standards and regulations:
- ASTM standard D 5250-00e4 (for Dimension, Physical Properties, and Powder Residual)
- 21 CFR 800.20 (for Freedom from pinholes - Waterleak Test)
- ASTM D6124-01 (for Powder Residual)
- ISO10993-10 (for Biocompatibility, specifically Primary Skin Irritation and Dermal Sensitization)
These standards specify the acceptable limits and test methods, which serve as the objective ground truth against which the device's performance is measured.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no training set. The evaluation focuses on the physical and chemical properties of the manufactured gloves.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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: KO73193 (applicant leave blank)
DEC 2 0 2007
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 : | SHIJIAZHUANG PROSPEROUS PLASTICCO.,LTD | |
|---|---|---|
| Submitter's address : | TAITOU HUAIAN ROAD, SHIJIAZHUANGCITY, HEBEI,050000,P.R.CHINA | |
| Phone number : | (86) 311-83021139 | |
| Fax number : | (86) 311-83021139 | |
| Name of contact person: | Ms. Xue Feng | |
| Date the summary was prepared: | Oct. 15,2007 |
[(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 GlovesOther 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 5250-0004.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0008.
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[(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 disposable device intended for medical 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 |
| and D6124-01 | <2mg/glove | |
| Biocompatability | Primary Skin Irritation inrabbits | Passes |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in theguinea pig | Passes | |
| Not a Dermal sensitization |
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-006, 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 notification submission for a determination of substantial equivalence .
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 AOL., meet labeling claims .
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2007
Shijiazhuang Prosperous Plastic Company, Limited C/O Mr. Chu Xiaoan Official Correspondent Room 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing, CHINA 100083
Re: K073193
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 15, 2007 Received: November 13, 2007
Dear Mr. 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 Federal Register.
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Page 2 - Mr. 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,
Susan Runner
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: SHIJIAZHUANG PROSPEROUS PLASTIC CO.,LTD
K073193 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, MD
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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.