(134 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)
The provided text describes the acceptance criteria and study for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".
Here's a 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 5250-06 | 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 in Rabbits (ISO10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal Sensitization | Dermal sensitization in the guinea pig (ISO10993-10) | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The testing is described as meeting established standards (ASTM, FDA regulations, ISO).
The data provenance is not explicitly mentioned as retrospective or prospective, nor are specific countries of origin for the data provided beyond the manufacturer's location in China. The testing is non-clinical, primarily relying on performance against established industry standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this device and its testing. The "ground truth" for these types of medical gloves is established by their adherence to defined physical, chemical, and biological performance standards, not by expert consensus in diagnostic interpretation. The standards themselves are developed by expert bodies.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For physical product testing against objective standards, the results are either pass or fail based on the standard's criteria.
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:
This is not applicable. This device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. This device is a physical product (a glove), not a software algorithm.
7. The type of ground truth used:
The ground truth is established by industrial and regulatory standards.
- Physical properties (Dimension, Physical Properties, Freedom from pinholes, Powder Residual): The ground truth is defined by the objective pass/fail criteria outlined in ASTM D 5250-06, ASTM D6124-06, and 21 CFR 800.20. These are quantifiable measurements and thresholds.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The ground truth is established by the results of biological tests on animal models, as per ISO10993-10, demonstrating the absence of harmful irritant or sensitizing reactions.
8. The sample size for the training set:
This is not applicable. This device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of its development or evaluation.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this device.
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"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(c)."
"The assigned 510(k) number is: [120397 7_ ." (applicant leave blank)
Premarket Notification [510(k)] Summary
I(a)(1)). The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax purchers, name of contact person, and date the summary was prepared :
| Submitter's name : | Shandong Shouguang KingLiYuan Medical Apparatus &Instrument Co.,Ltd |
|---|---|
| Submitter's address : | North of Xinhua Road & West of Dajiu Road, HouzhenProject Concentration Zone, Shouguang City, WeifangCity, Shandong Province, China |
| Phone number : | (86)536-5399866 |
| Fax number : | (86)536-5399990 |
| Name of contact person: | Mr. Hao Feng |
| Date the summary was prepared: | Mar. 13th, 2012 |
[(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 |
| 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 Gloves, 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 | Result of comparison | |
|---|---|---|---|---|
| Predicate device | Subject device | |||
| Dimension | ASTM standardD 5250-06 | Meets | Meets | substantial equivalence |
| Physical Properties | ASTM standardD 5250-06 | Meets | Meets | substantial equivalence |
| Freedom frompinholes | 21 CFR 800.20 | Meets | Meets | substantial equivalence |
| Powder Residual | ASTM standardD 5250-06and D6124-06 | Meets<2mg/glove | Meets<2mg/glove | substantial equivalence |
| Biocompatability | Primary SkinIrritation inrabbits | PassesNot a PrimarySkin Irritation | PassesNot a PrimarySkin Irritation | |
| Dermalsensitization inthe guinea pig | PassesNot a Dermalsensitization | PassesNot a Dermalsensitization | substantial equivalence |
[(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 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 . 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shandong Shouguang Kingliyuan Medical Apparatus & Instruments C/O Mr. Kevin Xu Dynasco America, Incorporated 916 West 21st Street Chicago, Illinois 60608
Re: K120797
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: June 20, 2012 Received: July 2, 2012
Dear Mr. Xu:
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.
JUL 2 7 2012
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Page 2 - Mr. Xu
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,
For
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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INDICATIONS FOR USE
Applicant: Shandong Shouguang KingLiYuan Medical Apparatus & Instrument 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 X (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)
Edith D. Clarence-Wells
(Division Sign-Off) (Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.