(196 days)
Powder Free Vinyl Patient Examination Gloves,White Color is a non-sterile 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,White Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
The provided text describes a medical device called "Powder Free Vinyl Patient Examination Gloves, White Color" and its substantial equivalence to a predicate device. This is a Class I device and the submission focuses on non-clinical performance criteria based on established standards.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 and D6124-06 | <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig (ISO 10993-10) | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, physical properties, etc.). However, it refers to compliance with established standards (ASTM D 5250-06 e1, ASTM D6124-06, 21 CFR 800.20, and ISO 10993-10). These standards would define the required sample sizes for testing.
The data provenance is from non-clinical testing conducted by the manufacturer, Suqian Ruijiang Medical Supplies Co., Ltd. The document does not specify the country of origin of the raw data, but the manufacturer is based in Suqian, Jiangsu, China. The testing described is retrospective in the sense that the results were generated prior to the 510(k) submission to demonstrate compliance with existing standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for this Class I medical device (patient examination gloves) is established by adherence to recognized regulatory standards and specifications, rather than expert consensus on complex diagnostic interpretations. The standards themselves define the acceptable parameters for glove performance.
4. Adjudication Method for the Test Set
This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or other subjective assessments. For this device, the "judgement" is determined by whether the test results meet the objective, quantitative criteria outlined in the referenced ASTM standards and FDA regulations.
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. This submission is for a basic medical device (examination gloves) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical product (gloves) and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used is based on established regulatory standards and objective test methods. Specifically:
- ASTM D 5250-06 e1: Standard for Vinyl Patient Examination Gloves. This standard specifies requirements for dimensions, physical properties (tensile strength, elongation), and other performance characteristics.
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves. This standard dictates the acceptable levels of powder residue.
- 21 CFR 800.20: This FDA regulation pertains to the freedom from pinholes (water leak test).
- ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. This standard sets the criteria for biocompatibility testing.
The "ground truth" is that the device must meet the specifications and pass the tests outlined in these standards.
8. The Sample Size for the Training Set
This information is not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant to machine learning algorithms, which are not involved here.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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Section C 510(k) Summary (21 CFR 807.92)
510(K) 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: 1( ( 1 ) 3 ) 94 "
Premarket Notification [510(k)] Summary
| Submitter's name : | Suqian Ruijiang Medical Supplies Co., Ltd. |
|---|---|
| Submitter's address : | No.119 Hongzhehu Road, Suqian, Jiangsu, 223800, China |
| Phone number : | 86-527-84391929 |
| Fax number : | 86-527-84391929 |
| Name of contact person: | Mr.Donmei Yu |
| Date the summary was prepared: | 2012-03-28 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves, White Color |
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves, White Color Other clients private labeling |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
Class I* Powder Free Vinyl Patient Examination Gloves, White Color that meets all of the requirements of ASTM D 5250-06 e1.
Predicate device: Powder-Free Vinyl Patient Examination Glove, White Color Tangshan Henda Plastic Products Co., Ltd. K102558.
Device Description: Powder Free Vinyl Patient Examination Gloves,White Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
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Device Intended Use(Indication for use): Powder Free Vinyl Patient Examination Gloves, White Color 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 summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Vinyl Patient Examination Gloves, White Color, 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 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1and D6124-06 | <2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbitsISO 10993-10Dermal sensitization in the guinea pigISO 10993-10 | PassesNot a Primary Skin IrritationPassesNot a Dermal sensitization |
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, White Color, meet requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1:2006.
The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
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.
The conclusions
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, White Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.
It can be concluded that the Powder Free Vinyl Patient Examination Gloves,White Color is as safe, as effective, and performs as well as the predicate device, Powder-Free Vinyl Patient Examination Glove, White Color Tangshan Henda Plastic Products Co., Ltd. K102558.
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Image /page/2/Picture/0 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 a stylized symbol featuring a stylized eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sugian Ruijiang Medical Supplies Company, Ltd. C/O Mr. Chu Xiaoan Consultant Beijing Easy-Link Company, Limited 1606 Building 1 Jian Xiang Yuan No. 209 Bei Si Huan Zhong Road Hai Dian District CHINA 100083
MAY 1 4 2012
Re: K113194
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, White Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 5, 2012 Received: April 9, 2012
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 - 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); 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/Safetv/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,
Cinnamon b. asa
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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Section B Indications for Use
INDICATIONS FOR USE
Suqian Ruijiang Medical Supplies Co., Ltd. Applicant:
510(k) Number (if known): *
Powder Free Vinyl Patient Examination Gloves, White Color Device Name:
Indications For Use:
Powder Free Vinyl Patient Examination Gloves,White Color is a non-sterile 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)
Elizabet T. Clavis-Wells
(Division Sign-Off) (Division Of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113194
§ 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.