(314 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 5250-06.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Device: Powdered 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 standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 | <10mg/dm2 (Also stated as "Meets") |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Dermal Sensitization in guinea pig | Passes (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 for each test (e.g., how many gloves were tested for pinholes, how many rabbits/guinea pigs for biocompatibility). It references standards (ASTM D 5250-06, 21 CFR 800.20, ISO10993-10), which would dictate the sample sizes and testing methodologies.
The provenance of the data is implicit: it's generated by the submitter (Tangshan Dar Plastic & Rubber Products Co., Ltd.) to demonstrate compliance with internationally recognized standards for their product. It is a prospective assessment of their manufactured device against established criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (patient examination gloves) does not typically involve expert review for its performance evaluation in the way a diagnostic imaging AI would. The "ground truth" for the performance criteria is established by the specified regulatory and industry standards themselves (ASTM D 5250-06, 21 CFR 800.20, ISO10993-10). These standards are developed by committees of experts in relevant fields (materials science, medical devices, toxicology, etc.), but the direct evaluation of this specific device's compliance is based on laboratory testing, not expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable. The performance is determined by objective laboratory testing against established physical, chemical, and biological criteria, not by human interpretation or adjudication of individual cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This device is a physical medical device (gloves), not a diagnostic algorithm where human readers would be "assisted" by AI. Therefore, an MRMC study is not relevant or performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used is a combination of:
- Industry and Regulatory Standards: ASTM standard D 5250-06, 21 CFR 800.20, and ISO10993-10. These standards define the acceptable limits and methodologies for evaluating the product's performance.
- Laboratory Test Results: Objective measurements from physical, chemical, and biocompatibility tests explicitly designed to determine compliance with the aforementioned standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set." The manufacturing process for gloves is typically validated through quality control and adherence to Good Manufacturing Practices (GMP).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
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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: KO3247 . " (applicant leave blank)
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 Dar Plastic & Rubber Products Co., Ltd. |
|---|---|
| Submitter's address : | Tangshan Sanxin High tech Industrial estate, TangguRoad, Tangshan city, Hebei province, 063100, P.R.China |
| Phone number : | (86) 315-5028910 |
| Fax number : | (86) 315-5028929 |
| Name of contact person: | Mr. Wang Jincheng |
| Date the summary was prepared: | Sept. 04, 2008 |
[(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 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* powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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 5250-06.
[(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 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 | Meets |
| Biocompatability | Primary Skin Irritation inrabbits | <10mg/dm2 |
| Passes | ||
| Dermal sensitization in theguinea pig | Not a Primary Skin Irritation | |
| 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 D5250-06, 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.
1(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that ((0)(3)) The consation 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 waterleak test on pinhole AQL, meet labeling claims .
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird with three wing-like shapes extending upwards and to the right, with two claw-like shapes below.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tangshan Dar Plastic & Rubber Products Company, Limited C/O Mr. Chu Xiaoan Chu Xiaoan Room 1606 Building 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Beijing 100083 CHINA
JUL 2 2 2009
Re: K082647
Trade/Device Name: Powdered Vinyl Patient Examination Glove, Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 23, 2009 Received: June 23, 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. Minton Jr.
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
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INDICATIONS FOR USE
Applicant: Tangshan Dar Plastic & Rubber Products Co., Ltd.
1408264 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)
Shula R. Murphy MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082647
§ 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.