(283 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 a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than a novel AI/ML medical device. Therefore, many of the requested categories (such as AI-specific study details, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this document.
The document outlines the acceptance criteria and the "device performance" in terms of meeting established standards for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported 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 (<10mg/dm2) |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | Dermal sensitization in the guinea pig | Passes (Not a Dermal Sensitization) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML algorithm. The performance evaluation is based on meeting industry standards and regulations for medical gloves. The tests for these characteristics are typically performed on representative samples from manufacturing batches. The document does not provide details on the sample sizes for these tests or their provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or measurements. For a medical glove, "ground truth" is established by adherence to physical, chemical, and biological performance standards defined by regulatory bodies and consensus organizations (e.g., ASTM, FDA). There is no mention of experts establishing a "ground truth" for a test set in the way it would be done for an AI/ML diagnostic device.
4. Adjudication method for the test set
Not applicable. There is no "test set" requiring adjudication in the context of an AI/ML algorithm. The evaluations are direct measurements against predefined standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for the device's performance is based on established industry standards and regulatory requirements. Specifically, these include:
- ASTM standard D 5250-00e4 (for dimension, physical properties, powder amount)
- 21 CFR 800.20 (for freedom from pinholes)
- ISO 10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization)
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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L072084
Summary
MAY - 8 2008
"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 ."
." (applicant leave blank) "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 : | ZIBO HONGYE SHANGQIN PLASTIC & RUBBER CO., LTD. |
|---|---|
| Submitter's address : | THE DEVELOPING TECHNICAL DISTRICT IN CROSS OFJIQING AND ZHANGTIAN EXPRESSWAY, ZIBO, 255000,P. R. CHINA |
| Phone number : | (86)- 533-3811696 |
| Fax number : | (86)- 533-3811696 |
| Name of contact person: | Ms. GENG Xiaocong |
| Date the summary was prepared: | Jul. 10,2007 |
[(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 GlovesClear (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 5250-0064.
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 | Primary Skin Irritation in rabbits | <10mg/dm2PassesNot a Primary Skin Irritation |
| Dermal sensitization in the guinea pig | PassesNot 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 D5250-0064, 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.
J(b)(3)] The conclusions drawn from the nonclinical 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 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 - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 8 2008
Mr. Chu Xiaoan Official Correspondent Zibo Hongye Shangqin Plastic & Rubber Products Company, Limited Room 1606 Building 1. Jianxiang Yuan, No. 209 Bei Si Huan Zhong Road Haidian District, Beijing 10083 P.R. CHINA
Re: K072084
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: April 11, 2008 Received: April 18, 2008
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 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 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 yours.
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: ZIBO HONGYE SHANGQIN PLASTIC & RUBBER 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)
Shale Murphy MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.