(74 days)
Powder free vinyl patient examination glove is a non-sterile 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 5250-06e1.
The device being described is "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)".
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06e1 | Meets |
| Physical Properties | ASTM standard D 5250-06e1 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06e1 and D6124-06 | <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits (AAMI/ANSI/ISO 10993-10) | Passes, Not a Primary Skin Irritation |
| Biocompatibility | Dermal sensitization in guinea pig (AAMI/ANSI/ISO 10993-10) | Passes, Not a Dermal sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., dimension, physical properties, pinholes, powder residual, biocompatibility studies). However, for these types of products and tests, standards like ASTM D5250-06e1 and 21 CFR 800.20 specify sampling plans and AQL (Acceptable Quality Level) for assessment.
The data provenance is not explicitly stated but can be inferred to be from prospective testing conducted by the manufacturer or a contracted lab to demonstrate compliance with the referenced standards. The country of origin of the data is not specified, but the manufacturer is based in China, suggesting the testing could have been performed there or by an accredited lab elsewhere.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for this device and its testing. The "ground truth" for glove performance testing is established by objective, quantitative measurements according to the specified ASTM and ISO standards, not by expert consensus or qualitative assessment. For example, pinhole freedom is assessed by a water leak test, and powder residual is measured gravimetrically. Biocompatibility tests are standardized animal studies.
4. Adjudication Method for the Test Set
This is not applicable for this device and its testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessment (e.g., medical image analysis) to resolve disagreements among readers. The tests performed for these gloves involve objective measurements against predefined criteria/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
This is not applicable. The device is a patient examination glove, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or assessment of AI assistance for human readers was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical product (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance is based on objective, quantitative measurements and standardized test methodologies defined by the referenced ASTM (e.g., D5250-06e1, D6124-06), ISO (e.g., 10993-10), and CFR (21 CFR 800.20) standards. These standards prescribe how to conduct tests for dimensions, physical properties, freedom from pinholes, powder residual, and biocompatibility (primary skin irritation, dermal sensitization).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As there is no training set for a physical device like a glove, there is no ground truth to be established for it.
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Section C 510(k) Summary (21 CFR 807.92)
510(k) Summary
DEC - 8 2009
:・
"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: KO929C6 " (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 : | Jin Zhou Chang Hao Plastic Products Co.,Ltd. | |
|---|---|---|
| Submitter's address : | Dong Dui Village Mayu Town,Jinzhou,Shi JiaZhuang City,Hebei Province,052260,China | |
| Phone number : | 86-311-84355868 | |
| Fax number : | 86-311-84355868 | |
| Name of contact person: | Ms.Gao Su | |
| Date the summary was prepared: | Sep 09.2009 |
[(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: | Powder Free Vinyl Patient Examination Gloves,Clear(non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination GlovesOther clients private labeling |
| Common Name: | Exam gloves |
| 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 5250-06e1.
Section C
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Passes
Not a Dermal sensitization
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 5250-06e1.
{(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.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1and D6124-06 | <2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbitsAAMI / ANSI / ISO ISO 10993-10 | PassesNot a Primary Skin Irritation |
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Dermal sensitization in the guinea pig
AAMI / ANSI / ISO ISO 10993-10
Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002.
[(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 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/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Jin Zhou Chang Hao Plastic Products Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company, Limited Room 1606 Building 1, Jian Xiang Yuan No. 209 Bei Si Huan Zhong Road Beijing CHINA 100083
DEC - 8 2009
Re: K092966
Trade/Device Name: Powder Free 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: November 4, 2009 Received: November 12, 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 (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.
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.
Susan Runner
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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Section B Indications for Use
"INDICATIONS FOR USE
Jin Zhou Chang Hao Plastic Products Co.,Ltd. Applicant: K092966 510(k) Number (if known): * Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored) Device Name:
Indications For Use:
Powder free vinyl patient examination glove is a non-sterile 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)
Elliott F. Clavius-Wills
Jivision Sign-Off) Jivision Sign-Off)
Tivision of Anesthesiology, General Hospital Section B(rev.01) nfection Control, Dental Devices
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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.