(95 days)
Powdered 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.
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00"4.
The provided text describes the acceptance criteria and performance of a medical device, specifically Powdered Vinyl Patient Examination Gloves, Clear (Non-colored). It relies on non-clinical testing rather than clinical studies involving human patients or complex algorithms.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Meets ASTM standard D 5250-00e4 requirements | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets ASTM standard D 5250-00e4 requirements | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets 21 CFR 800.20 requirements (waterlearly cest on pinhole AQL) | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Meets ASTM standard D 5250-00e4 requirements | Meets |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO10993-10) | Passes, Not a Primary Skin Irritation | Passes, Not a Primary Skin Irritation |
| Dermal sensitization in the guinea pig (ISO10993-10) | Passes, Not a Dermal sensitization | Passes, Not a Dermal sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the tests performed (e.g., number of gloves tested for pinholes, or number of animals for biocompatibility).
The data provenance is from non-clinical tests performed by the manufacturer (Tangshan Luxiong Plastic Products Co.,Ltd) to ensure compliance with established standards (ASTM, CFR, ISO). It is retrospective in the sense that the tests were performed on the manufactured product to demonstrate its characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device. The "ground truth" for these performance criteria is established by objective engineering and biocompatibility standards (ASTM, CFR, ISO), not by expert human interpretation. The outcomes are binary (pass/fail) or quantitative measurements compared against predefined thresholds.
4. Adjudication Method for the Test Set
Not applicable. As described above, the assessments are based on objective measurement against established standards, not on human interpretation 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 relevant for diagnostic imaging devices or algorithms that human readers interpret. This device is a patient examination glove, and its effectiveness is determined by its physical and biological properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. It is a physical medical device (gloves).
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established objective laboratory test methods and standardized metrics as defined by:
- ASTM standard D 5250-00e4 (for dimensions, physical properties, powder amount)
- 21 CFR 800.20 (for freedom from pinholes)
- ISO10993-10 (for biocompatibility testing - primary skin irritation and dermal sensitization)
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, this question is not relevant.
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Summary K61659
"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
[(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: | Powdered Vinyl Patient Examination Gloves, Clear (Non-colored) |
|---|---|
| Proprietary/Trade name: | Powdered Vinyl Patient Examination Gloves, Other 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* powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0064.
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.
[(a)(4)] A description of the device
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Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00"4.
(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered 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 powdered vinyl patient examination gloves, Clear (non-colored) 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 Amount | ASTM standard D 5250-00e4 | Meets |
| Biocompatability | <10mg/dm2 | |
| Primary Skin Irritation in rabbits | Passes | |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in the guinea pig | Passes | |
| Not a Dermal sensitization |
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powdered vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-00-4, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.
[(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 Powdered Vinyl Patient Examination Gloves, Clear(non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterlearly cest 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 and Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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 Bei Si Huan Zhong Road Haidian District Beijing, China 100083
Re: K061659
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves 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 III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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 (OS) 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 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
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: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)
Indications For Use:
Powdered 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)
Shule H. Mingly, M.D. M.J.T.C.
Anesthesiology, General Hospital, on Control, Dental Device
: Number. 14/654
§ 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.