(63 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) that meets all of the requirements of ASTM standard D 5250-06.
Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)":
This device, a patient examination glove, is a Class I medical device, which typically requires less rigorous testing than higher-class devices. The primary focus of the testing is to demonstrate substantial equivalence to a predicate device and adherence to recognized standards.
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 Residual | ASTM standard D 5250-06, D6124-06 | <2mg/glove |
| Biocompatibility (Irritation) | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Sensitization) | 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 the specific sample sizes used for each test (e.g., for dimension, physical properties, pinholes, powder residual, or biocompatibility). It references adherence to standards like ASTM D5250-06, 21 CFR 800.20, and ISO10993-10, which would typically specify minimum sample sizes for individual tests.
The data provenance implies that the testing was conducted by the manufacturer, SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD, located in China. The testing appears to be prospective as it was conducted specifically for this 510(k) submission to demonstrate compliance with the standards.
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 glove) does not typically involve human expert interpretation of results in the way, for example, a diagnostic imaging AI algorithm would.
- For physical and chemical tests (Dimension, Physical Properties, Freedom from pinholes, Powder Residual), the "ground truth" is established by the specifications of the referenced ASTM standards and 21 CFR regulations. The results are quantitative measurements compared against predefined thresholds.
- For biocompatibility tests (Primary Skin Irritation, Dermal Sensitization), the "ground truth" is established by observing animal responses (rabbits for irritation, guinea pigs for sensitization) against established protocols (ISO 10993-10) and interpretation by trained toxicologists or scientists. The number and specific qualifications of these experts are not stated in this summary, but would be implicit in the conduct of these standardized tests.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense. The "adjudication" is essentially the direct comparison of measured device characteristics against the objective, pre-defined criteria in the referenced standards. There isn't a scenario described where multiple interpretations of data would require an adjudication process by human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically conducted for diagnostic devices where human readers (e.g., radiologists) interpret medical images or data, and the study compares their performance with and without AI assistance. A patient examination glove is a simple barrier device, not a diagnostic tool, so an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is also not relevant. The device is a physical product (a glove), not an algorithm. The performance is assessed through laboratory testing of its physical and biological properties.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by:
- Standard Specifications: For mechanical properties (dimension, physical properties, pinholes, powder residual), the ground truth is the quantitative limits defined by ASTM standards (D 5250-06, D6124-06) and 21 CFR 800.20.
- Biological Response Protocols: For biocompatibility, the ground truth is determined by the observed biological reactions in animal models following the established protocols of ISO 10993-10 (often interpreted as "Pass" or "Fail" based on whether reactions exceed certain thresholds).
Essentially, it's a combination of objective measurement against predefined criteria and standardized biological testing outcomes.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no "training set."
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: ______________________________________________________________________________________________________________________________________________
MAY 1 3 2010
. :
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 UNIVERSAL CHANNEL PLASTIC CO.LTD |
|---|---|
| Submitter's address : | INDUSTRIAL PARK, PINGSHAN COUNTY,SHIJIAZHUANG, 050000, CHINA |
| Phone number : | (86) 311-83985366 |
| Fax number : | (86) 311-83986358 |
| Name of contact person: | Mr. Mike Xu |
| Date the summary was prepared: | Feb 25nd 2010 |
[(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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Device Description : powder free 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: 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.
The powder free vinyl patient examination gloves, 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 Residual | ASTM standard D 5250-06 | Meets |
| Biocompatability | and D6124-06 | <2mg/glove |
| Primary Skin Irritation in rabbits | Passes | |
| Dermal sensitization in the guinea pig | Passes | |
| Not a Primary Skin Irritation | ||
| Not a Dermal sensitization |
[(b)(1)] A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. , it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses.
[(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 and clinical 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 , Clear(non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .. It is as safe,as effective, and performed as well the legally marketed device identified in (a)(3).
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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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shijiazhuang Universal Channel Plastic Company, Limited C/O Mr. Chu Xiaoan Office Correspondent Room 1606 Building, 1 Jianxiang, Yuan No. 209 BEI SI Huan Zhong Road, Haidian District, Beijing China 100083
MAY 1 3 2010
Re: K100697
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: February 25, 2010 Received: March 11, 2010
Dear Mr. Chu 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2- Mr. Chu 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/ReportalProblem/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,
NON upper
/Anthony D. Watson, B.S., M.S., M.B.A. 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 UNIVERSAL CHANNEL PLASTIC CO., LTD
510(k) Number (if known):_*
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 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)
signature
Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
-10(k) Number: k:100697
§ 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.