(48 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 5250-06.
This document describes the acceptance criteria and the study that proves the device meets those criteria for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D 5250-06 | Meets |
| Physical Properties | ASTM D 5250-06 | Meets |
| Freedom from Pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 5250-06 and D6124-06 | < 2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits (AAMI/ANSI/ISO 10993-10:2002) | Pass (Not a Primary Skin Irritation Body-part) |
| Dermal sensitization in guinea pigs (AAMI/ANSI/ISO 10993-10:2002) | Pass (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, the tests are conducted in accordance with referenced ASTM standards and FDA regulations, which would stipulate appropriate sample sizes for each type of test. The data provenance is not specified beyond being generated through testing against established standards. Given the context of a 510(k) submission, this data is typically generated prospectively during the device development and testing phase to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for the performance of these gloves is established by objective, standardized laboratory tests according to predefined specifications (e.g., ASTM standards, CFR regulations). It does not rely on expert consensus or adjudication in the medical diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective evaluations, typically in clinical studies or image interpretations. The performance of these gloves is assessed through objective, quantitative laboratory measurements against established standards, without the need for human adjudication of results in that manner.
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 information is not applicable. The device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical glove and does not involve any algorithms or AI for its function.
7. The Type of Ground Truth Used
The ground truth used for evaluating the performance of the gloves is established by:
- Standardized Test Methods: Adherence to specific ASTM International standards (D 5250-06, D6124-06) for physical properties, dimensions, and powder residual.
- Regulatory Requirements: Compliance with 21 CFR 800.20 for freedom from pinholes.
- Biocompatibility Standards: Adherence to AAMI / ANSI / ISO 10993-10:2002 for primary skin irritation and dermal sensitization.
These standards and regulations define the objective criteria that the device must meet.
8. The Sample Size for the Training Set
This information is not applicable. The device is a medical glove and does not involve machine learning or AI, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this type of device.
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JUL 8 7 2009 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: K09 1 (0 (0 1 . . " (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the (14)(2); The summin) , cos, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | ZHANGJIAGANG HUAYUAN PLASTIC CO.,LTD. |
|---|---|
| Submitter's address : | Guang Ming Road, Industrial Concentration DistrictTangqiao, Zhangjiagang, Jiangsu, 215615 China |
| Phone number : | (86) 512-58416682 |
| Fax number : | (86) 512-58416588 |
| Name of contact person: | Mr. Yeo Yee Teng |
| Date the summary was prepared: | May 29, 2009 |
((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
Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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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 Device intention ever powedical 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 | Pass |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in theguinea pig | PassNot a Dermal sensitization |
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the ((0)(-)) =====================================================================================================================================================================
Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements oer ASTM Fowder free viry patch onamilation gioved , end FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002.
[(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 .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, rendered in a stylized, flowing design.
Public Health Service
JUL 2-7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zhang Jia Gang Fengyuan Plastic Products Company, Limited C/O Mr. Chu Xiaoan Chu Xiaoan Room 1606 Building 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing 100083 P, R. CHINA
Re: K091661
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: May 30, 2009 Received: June 9, 2009
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 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); 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. Matin for
S. B. B. S. M. A.
Susan Runner, D.D.S., M.A. Acting 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:_ZHANGJIAGANG HUAYUAN PLASTIC CO.,LTD.
510(k) Number (if known): * KO91661
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)
Shula R. Murphy MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091661
§ 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.