(95 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 5250-00ed.
The document describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)" manufactured by Tangshan Luxiong Plastic Products Co.,Ltd. The submission is a 510(k) premarket notification, indicating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard | Acceptance Criteria | Device Performance |
|---|---|---|---|
| Dimension | ASTM D 5250-00e4 | Meets ASTM standard D 5250-00e4 | Meets |
| Physical Properties | ASTM D 5250-00e4 | Meets ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 5250-00e4, D6124-01 | <2mg/glove (per D6124-01) | <2mg/glove |
| Biocompatibility (Primary Skin Irritation) | (Not explicitly stated, generally ISO 10993) | Passes | Passes |
| Biocompatibility (Dermal Sensitization) | (Not explicitly stated, generally ISO 10993) | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set for each characteristic. It refers to compliance with standards (ASTM D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, and ISO10099-10), which would imply testing was conducted according to the methodology outlined in these standards.
The data provenance is not specified in terms of country of origin or retrospective/prospective nature. However, since it's a 510(k) submission for a medical device manufacturer in China, the testing was likely performed by the manufacturer, or a contracted lab, to demonstrate compliance with the referenced international/US standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
Not applicable. This submission is for medical gloves, and the evaluation relies on adherence to established material and performance standards, not on expert interpretation of complex data or images for ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. The evaluation is based on objective measurements and compliance with specified standards, not on subjective expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted diagnostic devices to assess the impact on human reader performance, which is not relevant for medical gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical glove and does not involve an algorithm or AI.
7. The Type of Ground Truth Used:
The "ground truth" for this device is defined by the technical specifications and performance requirements outlined in the referenced standards:
- ASTM standard D 5250-00e4: Specifies requirements for physical properties and dimensions of vinyl patient examination gloves.
- 21 CFR 800.20: Defines the "waterleak test" for freedom from pinholes in medical gloves.
- ASTM standard D6124-01: Specifies methods for determining residual powder on medical gloves.
- Biocompatibility standards (implied by "Passes" for skin irritation and sensitization): These generally refer to ISO 10993 series and involve standardized biological reactivity tests.
8. The Sample Size for the Training Set:
Not applicable. This device is a manufactured product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI/ML device, there is no training set or ground truth established in that context. The "ground truth" for compliance testing is inherently defined by the objective metrics and thresholds within the referenced ASTM, FDA, and ISO standards for the glove's physical and biological properties.
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Kob1662
Summary
SEP 15 2006
"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: ______________________________________________________________________________________________________________________________________________
Premarket Notification [510(k)] Summary
1(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 : | Tangshan Luxiong Plastic Products Co.,Ltd | |
|---|---|---|
| Submitter's address : | Pachigang, Luannan County, Tangshan, Hebei, 063500, P. R. China | |
| Phone number : | (86)315-4169201 | |
| Fax number : | (86)315-4169311 | |
| Name of contact person: | Ms. Zhang Liang | |
| Date the summary was prepared: | June 08, 2006 |
[(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 5250-00-4.
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 5250-00ed.
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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 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 | Meets |
| Biocompatability | and D6124-01 | <2mg/glove |
| Primary Skin Irritation in rabbits | Passes | |
| Dermal sensitization in the guinea pig | Passes |
[(b)(1)] 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 , Clear(non-colored) meet requirements per ASTM D5250-0064, per ASTM D6124-01, per 21 CFR 800.20 and 1SO10099-10.
[(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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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 stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
SEP 1 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chu Xiaoan Tangshan Luxiong Plastic Products Company, Limited Room 1606. Building 1. Jianxiang Yuan No. 209 Bci Si Huan Zhong Road Haidian District Beijing, China 100083
Rc: K061662
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves. Clear (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 21, 2006 Received: August 28, 2006
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 Hi (PMA). it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on vour responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chris
Chiu Lin. Ph.D. 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: Tangshan Luxiong Plastic Products 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 (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)
Shuler M. Ringleb, M.D.
Anesthesiology. General Hosphal on Control. Dental Devic
1116551
§ 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.