(52 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)
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)":
This document describes a 510(k) premarket notification for a medical device -- Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The studies conducted are non-clinical, primarily focused on meeting established material and performance standards for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21-CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | Meets (<2mg/glove) |
| Biocompatibility: | ||
| - Primary Skin Irritation | Primary Skin Irritation in rabbits Passes | Passes (Not a Primary Skin Irritation) |
| - Dermal Sensitization | Dermal sensitization in the guinea pig Passes | Passes (Not a Dermal Sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the specific sample sizes for each test (e.g., number of gloves tested for pinholes, dimension, physical properties, or the number of animals for biocompatibility tests). It relies on adherence to the referenced ASTM and CFR standards, which would prescribe appropriate sample sizes within those methodologies.
- Data Provenance: The testing was conducted by or on behalf of YONGSHENG PLASTIC CO., LTD in China. The data would be retrospective in the sense that the tests were performed to demonstrate compliance after the gloves were manufactured, rather than as part of a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This type of non-clinical testing does not typically involve "experts" in the sense of clinical specialists establishing a "ground truth." The ground truth for these tests is defined by the objective, quantitative criteria outlined in the referenced industrial and regulatory standards (ASTM D 5250-06, D6124-06, 21 CFR 800.20, ISO10993-10). Testing laboratories with appropriate accreditation and expertise in materials science, mechanical testing, and biocompatibility testing would perform these evaluations. The qualifications of the personnel performing these tests are implied to meet the requirements of the respective standards and regulatory bodies.
4. Adjudication Method for the Test Set
No adjudication method (like 2+1, 3+1 consensus) is described or applicable here. The evaluation of the device's performance against the acceptance criteria is based on objective measurement and observation as per the specified standards. The results either "Meet" or "Pass" the predefined numerical and qualitative thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and the impact of AI assistance on their performance is measured. For a simple medical device like an examination glove, such a study is not applicable.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) study was not done. This device is a physical product (a glove), not an algorithm or AI software. Therefore, the concept of "algorithm only" performance is not applicable. The studies performed directly assess the physical properties and biological safety of the glove itself.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established industry standards and regulatory requirements. This includes:
- Measurement Standards: ASTM standard D 5250-06 for dimensions and physical properties.
- Regulatory Limits: 21 CFR 800.20 for freedom from pinholes, and D6124-06/D5250-06 for powder residual (quantified as <2mg/glove).
- Biocompatibility Standards: ISO10993-10 for primary skin irritation and dermal sensitization, which define "passes" based on specific tissue reactions in animal models.
8. The Sample Size for the Training Set
This device does not utilize a "training set" in the context of machine learning or AI. Therefore, there is no sample size for a training set. The device is a manufactured physical product whose performance relies on its material composition and manufacturing process, not on a learned algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this product, the question of how its ground truth was established is not applicable.
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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: ______________________________________________________________________________________________________________________________________________
DEC 2 0 2010
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 : | YONGSHENG PLASTIC CO., LTD | |
|---|---|---|
| Submitter's address : | NEW INDUSTRIAL PARK, XINXIANG CITY,453003, CHINA | |
| Phone number : | (86) 373-2588628 | |
| Fax number : | (86) 373-2588627 | |
| Name of contact person: | Mr. Wu Wei | |
| Date the summary was prepared: | October 14th, 2010 |
[(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 5250-06.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
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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 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21-CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | Meets |
| and D6124-06 | <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 non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. , it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses.
[(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 tests that demontrate that demonstrate that (UN-)) The concidentive, 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 , Cleves , Clear on It call be concluded that the Forraci restandard and FDA requirements for waterleak test on meet the AQL., meet labeling claims. It is as safe,as effective, and performed as well the legally marketed device identified in (a)(3).
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized abstract symbol to the right, which is composed of three curved lines that resemble a person with outstretched arms. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Chu Xiaoan Quality Assurance Manager Rm. 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Hai Di Beijing China 100083
DEC 2 0 2010
Re: K103198
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 14, 2010 Received: October 29, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Wei
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. 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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K103/98
INDICATIONS FOR USE
Applicant: YONGSHENG PLASTIC CO., LTD
510(k) Number (if known): *
DEC 2 0 2010
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)
Elliott F. Laurie-Wells
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103198
§ 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.