(80 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 the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
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 | Meets (<10mg/dm2) |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility | Dermal sensitization in the guinea pig | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a sample size for the test set. It mentions "Powdered vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM PRO10002 10 Fowdered - viryl patient channel pro 21 CFR 800.20 and ISO10993-10," implying that these standards' specified testing methodologies (which would include sample sizes) were followed. However, the specific numbers are not provided.
The data provenance is not explicitly mentioned but based on the submitter's address (CHINA) and the general nature of compliance testing for medical devices, it is highly likely the data was generated in China and is prospective (i.e., new testing conducted for the submission).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The standards (ASTM, CFR, ISO) would define the methodology for establishing conformity, which might involve expert assessment, but the document does not elaborate on the expert involvement or their qualifications for the specific tests.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set. The tests appear to be objective measurements against defined standards rather than interpretations requiring adjudication among multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. This device is a patient examination glove, which does not involve human interpretation in the same way.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone performance evaluation was done. The device's performance was measured directly against established standards (ASTM, 21 CFR, ISO) for its physical, chemical, and biological properties. This testing does not involve human-in-the-loop interaction for performance evaluation; it's about the inherent qualities of the glove itself.
7. Type of Ground Truth Used:
The ground truth used is primarily objective measurements against established industry and regulatory standards. These standards define acceptable ranges or thresholds for characteristics like dimensions, physical properties, pinholes, and powder amount. For biocompatibility, the ground truth is derived from the results of standardized animal testing (rabbit irritation, guinea pig sensitization).
8. Sample Size for the Training Set:
This information is not applicable to this device and its evaluation methods. Training sets are relevant for machine learning algorithms. The evaluation of a patient examination glove relies on physical, chemical, and biological testing against predefined standards, not on algorithms trained on data.
9. How Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of 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: KO 91521 . " (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 : | SHIJIAZHUANG CENTURY PLASTIC CO., LTD |
|---|---|
| Submitter's address : | RM 1101, UNIT 3, #2 BUILDING, XINTONG GARDEN, #188BEIXIN ST, SHIJIAZHUANG, 050000, CHINA |
| Phone number : | (86)- 311-83986806 |
| Fax number : | (86)- 311-88766889 |
| Name of contact person: | Ms. Lisa Zhang |
| Date the summary was prepared: | May 15, 2009 |
[(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, Shijazhuang Fuguan Plastic Products Co., Ltd.. K032907.
[(a)(4)] A description of the device
Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered vinyl patient examination glove, Clear(non-colored) bettle="firended ober" polices ou" "11/1" proves 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 The powdered virth 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 |
| <10mg/dm2 | ||
| Biocompatability | Primary Skin Irritation inrabbits | Passes |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in theguinea pig | Passes | |
| Not a Dermal sensitization |
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the [(0)(1)] A Diffication submission for a determination of substantial equivalence .
Powdered vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM
PRO10002 10 Fowdered - viryl patient channel pro 21 CFR 800.20 and ISO10993-10.
[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket [(0)(2)] A Drier discussion 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 ((b)(3)) I he conclusions urawn from the nonemas 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) It can be concluded that the Fowdered valy. Fallen Enablements 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 Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG I 0 2009
Mr. Chu Xiaoan Official Correspondent Shijiazhuang Century Plastic Company, Limited Rm 1606 Building 1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District, Beijing 100083 P.R. China
Re: K091521
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 27, 2009 Received: August 4, 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/CDRH Offices/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.
Anthony V. Muster du
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
Enclosure
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INDICATIONS FOR USE
Applicant: SHIJIAZHUANG CENTURY PLASTIC 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 X (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)
Shela P. Murphy, 10
Division Sign-Off) ·vision of Anesthesiology, General Hospital niection Control, Dental Devices
510(k) Number: K091521
§ 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.