(50 days)
Powder free 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.
Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)
The provided document describes the safety and effectiveness information for Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) submitted by SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO., LTD., under K092415.
Here's an analysis of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Acceptance Criteria | Device Performance |
|---|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets the standard | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets the standard | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets the standard | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | <2mg/glove | <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits | Not a Primary Skin Irritation | Passes |
| Dermal sensitization in the guinea pig | Not a Dermal Sensitization | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of typical AI/ML studies focusing on diagnostic accuracy. The performance data presented are based on adherence to established material and safety standards for medical gloves.
- Sample Size: Not explicitly stated for each test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). The claim is that the device "Meets" the specified standards, implying an adequate sample size was used to demonstrate compliance according to those standards.
- Data Provenance: The studies were conducted by the manufacturer, SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO., LTD., likely in China, as that is the submitter's country of origin. The studies are retrospective in the sense that they are engineering and biocompatibility tests conducted on manufactured product batches to ensure compliance with pre-defined standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and submission. This is a 510(k) submission for a Class I patient examination glove, which relies on demonstrating conformance to recognized consensus standards and biocompatibility tests, not on expert interpretations of medical images or clinical outcomes. The "ground truth" for these tests is defined by the objective metrics and methodologies outlined in the ASTM standards and FDA regulations (e.g., 21 CFR 800.20, ISO10993-10).
4. Adjudication method for the test set
This is not applicable. The "adjudication method" concept typically applies to studies where human experts are making subjective assessments that need to be reconciled (e.g., reading medical images). Here, the tests are objective measurements and evaluations against predefined criteria in 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers. This device is a medical glove, for which AI assistance for human readers is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical product (a glove), not an algorithm or software. Therefore, this question is not relevant.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Standard Specifications: Adherence to the defined dimensional, physical, and powder residual limits set forth in ASTM standard D 5250-06 and D6124-06.
- Regulatory Requirements: Compliance with 21 CFR 800.20 for freedom from pinholes.
- Biocompatibility Test Results: Objective results from standardized animal tests (Primary Skin Irritation in rabbits, Dermal sensitization in guinea pig) showing "Passes" and "Not a Primary Skin Irritation" / "Not a Dermal Sensitization," as per ISO10993-10.
8. The sample size for the training set
The concept of a "training set" is not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set" for this device.
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SEP 2 5 2009
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: ______________________________________________________________________________________________________________________________________________
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 ELEGANCE PLASTICPRODUCTS CO., LTD. | |
|---|---|---|
| Submitter's address : | RM 201, UNIT 2, #15 BUILDING,ZHONGYUAN, #88 HUAIAN WEST RD,SHIJIAZHUANG, 050000, CHINA | |
| Phone number : | (86) 311-83986806 | |
| Fax number : | (86) 311-83986358 | |
| Name of contact person: | Robert Green | |
| Date the summary was prepared: | July.29nd, 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: | 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* powder free vinyl patient examination gloves , Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
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[(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 Device intended over powed. Incomedial 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 powder free vinyl patient examination gloves, non sterile are summarized with the following The powder free viry paris. 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 Residual | ASTM standard D 5250-06 | Meets |
| and D6124-06 | <2mg/glove | |
| Biocompatability | Primary Skin Irritation in | Passes |
| rabbits | Not a Primary Skin Irritation | |
| Dermal sensitization in the | Passes | |
| guinea pig | 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 .
Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per Fowder the vinyl patient exammation groves , 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 brici 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)) The conclusions urawn from the nomed 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 It can be concluded that the FOWGEr Frice Valy. Paterleak test on pinhole AQL, meet labeling claims .
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three stripes above it.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Shijiazhuang Elegance Plastic Products Company, Limited C/O Mr. Chu Xiaoan Chu Xiaoan Room 1606 Building 1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing CHINA 100083
SEP 2 5 2009
Re: K092415
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: July 29, 2009
Received: August 6, 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/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 vours.
Anton Dianta h
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: SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO., LTD.
510(k) Number (if known):长0924レS
Device Name: _ Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored)
Indications For Use:
Powder free vinyl patient examination glove is a disposable device intended for medical Powder life villy patient examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use Prescription 6001 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)
Rafiq Rangulin'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092415
§ 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.