(134 days)
The powder free light yellow stretch 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. It has light yellow color and is sold as non sterile.
Powder free light-yellow stretch vinyl patient examination gloves are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. They have light yellow color.
The provided document describes the acceptance criteria and a study demonstrating that the "Powder Free Light-Yellow Stretch Vinyl Patient Examination Gloves" meet these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against several ASTM and ISO standards. The table below summarizes these.
| Description | Acceptance Criteria (Standard Reference) | Reported Device Performance (Our Device) |
|---|---|---|
| Dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Primary Skin Irritation (ISO 10993-10) | Passes | Passes |
| Dermal Sensitization (ISO 10993-10) | Passes | Passes |
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., number of gloves tested for pinholes, skin irritation, etc.). It only mentions that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." The data provenance is from Wealth On (Jiangsu) Co., Ltd, China, and the tests were likely conducted prospectively as part of the 510(k) submission for the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by objective, standardized testing methods (ASTM, ISO) rather than expert consensus on subjective evaluations.
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective and based on established physical and biological testing procedures, not on subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
This information is not applicable. This is a submission for a medical device (patient examination gloves), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. As mentioned above, this is not an AI algorithm. The performance evaluation is for the physical and biological properties of the gloves themselves.
7. The Type of Ground Truth Used
The ground truth used is based on objective measurements and results obtained through standardized laboratory testing according to ASTM and ISO standards for physical properties and biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such devices would be the manufacturing process itself, ensuring consistency and quality control.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" in the context of this device. The standards (ASTM, ISO) themselves define the acceptable performance characteristics, and the manufacturing process aims to consistently produce gloves that meet these predefined criteria.
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Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification
JUL 1 0 2012
Wealth On (Jiangsu) Co., Ltd Dongyuan Village, Hengji Town, Jianhu County Yancheng, Jiangsu Province, China Tel: 86-21-33517339 Submitter's FDA Registration Number: 3009307502
US Agent and Contact Person
Charles Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: Feb 12, 2012
Device Name: Proprietary Name:
Common Name: Classification Name: Device Classification: Regulation Number: Panel: General Product Code:
Powder Free Light-Yellow Stretch Vinyl Patient Examination Gloves (or other clients private labeling) Patient examination glove Patient examination glove I 21 CFR 880.6250 Hospital LYZ
Predicate Device Information:
(1) K110219, "Powder Free Vinyl Patient Examination Gloves", manufactured by "Wealth On (Jiangsu) Co., Ltd" (our own company)
Device description:
Powder free light-yellow stretch vinyl patient examination gloves are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. They have light yellow color.
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Intended Use:
The powder free light-yellow stretch 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. It has light yellow color and is sold as non sterile.
Comparison to Predicate Devices
The powder free light-yellow stretch vinyl patient examination gloves, non sterile are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
(1) K110219, "Powder Free Vinyl Patient Examination Gloves", manufactured by "Wealth On (Jiangsu) Co., Ltd" (our own company)
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Our Device | Predicate Device (K110219) |
|---|---|---|
| Indication forUse | Disposable device intended for medicalpurposes that is worn on the examiner's handor finger to prevent contamination betweenpatient and examiner. | Same |
| Basic Design | A garment covering the hand and wrist area.Gloves have separate sheaths or openings foreach finger and the thumb. | Same |
| Materials | Poly Vinyl Chloride | Same |
| Size | XS, S, M, L, XL | Same |
| Single Use | Yes | Yes |
| Color | Light Yellow | Colorless |
| Sterile | Non sterile | Non sterile |
Table 5.1: Comparison of Intended Use, Design, and Material
The only difference is that the predicate device is colorless and does not contain any pigment. The new device contains white and yellow pigments and color is light yellow. The MSDS of the pigments are in Appendix 2 and they are both non-hazardous materials. The gloves made using these pigments have shown to not causing irritation and sensitization effects (Section 15: Biocompatibility).
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The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Powder Free Light-Yellow Stretch Vinyl Patient Examination Gloves (or other clients private labeling), manufactured by "Wealth On (Jiangsu) Gloves Co., Ltd" met all relevant requirements in the test standards, and are comparable to the predicate device.
| Description | Our Device | Predicate Device (K110219) |
|---|---|---|
| Dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Primary SkinIrritation(ISO 10993-10) | Passes | Passes |
| Dermal sensitization(ISO 10993-10) | Passes | Passes |
| Table 5.2: Comparison of Physical, Biocompatibility and Performance Testing | |||
|---|---|---|---|
More details of non-clinical tests are summarized in Sections 15 & 18.
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 user-defined acceptance criteria and intended uses:
Powder free light-yellow stretch vinyl patient examination gloves meet requirements per ASTM D5250-06, ASTM D6124-06, ASTM D 5151-06, and ISO 10993-10. It is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses.
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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.
Substantial Equivalent Conclusions
Based on the comparison of intended use, design, materials, and performance, our powder free light-yellow stretch vinyl examination gloves are substantial equivalent to its predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the edge of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Wealth On Jiangsu Company, Limited C/O Mr. Charles Shen Manton Business and Technology Services 5 Carey Street Pennington, New Jersey 08534
JUL 1 0 2012
Re: K120584
Trade/Device Name: Powder Free Light-Yellow Stretch Vinyl Patient Examination Gloves (or other clients Private Labeling) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 31, 2012 Received: May 31, 2012
Dear Mr. Shen:
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. Shen
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
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Section 4: Indications for Use
510(k) Number (if known): N/A K / 2 058 G Device Name: Powder Free Light-Yellow Stretch Vinyl Patient Examination Gloves (or other clients private labeling)
Indications for Use:
The powder free light yellow stretch 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. It has light yellow color and is sold as non sterile.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clavie-Williams
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120584
§ 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.