(48 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064.
The provided document describes the "Powder Free Vinyl Patient Examination Gloves, white (non-colored)" and its premarket notification (510(k)) summary. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study of device performance against specific acceptance criteria using a test set. This type of submission relies on established standards and non-clinical testing.
Here's an analysis of the available information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (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 Residual | ASTM standard D 5250-00e4 and D6124-01 | Meets (<2mg/glove) |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility | Dermal sensitization in guinea pig | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the testing mentioned (e.g., for dimension, physical properties, pinholes, powder residual, or biocompatibility). It only indicates that the device "Meets" the respective standards. The data provenance is not specified, but the device manufacturer is ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD in China. The testing would have been conducted by or for this company. This testing would be considered prospective, as it's conducted to demonstrate compliance for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device's performance is assessed against established ASTM and CFR standards, not through expert consensus on a subjective test set. The standards themselves define objective metrics. For biocompatibility, animal models (rabbits and guinea pigs) were used, not human experts to establish "ground truth" in the way one would for image interpretation, for example.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Device performance is measured directly against technical standards, not through expert adjudication of subjective results.
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 device is a disposable medical glove, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a physical medical device like a glove. The "standing alone" performance refers to the device's inherent characteristics as measured against specified standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for evaluating the performance of these gloves is defined by:
- Established ASTM Standards: These provide quantitative and qualitative specifications for dimensions, physical properties (e.g., tensile strength, elongation), and powder residual.
- Regulatory Standards (21 CFR 800.20): Specifically for freedom from pinholes, which dictates an Acceptable Quality Level (AQL) for water leak testing.
- Biocompatibility Standards (ISO10993-10): These guide the animal testing for primary skin irritation and dermal sensitization. The "ground truth" for these tests is the observed biological response in the animal models according to the standard's interpretation guidelines (e.g., absence of irritation).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device. The physical characteristics and biological safety of gloves are determined through standardized testing, not machine learning or algorithm training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
C Summary
JUN 2 1 2005
"This summary of 510(k) safety and effectiveness information is heing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 "
"The assigned 510(k) number is: 05 11 4 8 __ ." (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 : | ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD |
|---|---|
| Submitter's address : | NO. 208 YIXI ROAD, LINZI DISTRICT, ZIBO CITY,SHANDONG PROVINCE, 255411, P.R.CHINA |
| Phone number : | (86) 533-7488136 |
| Fax number : | (86) 533-7524666 |
| Name of contact person: | Chen Yan |
| Date the summary was prepared: | 06. April, 2005 |
[(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, white(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 , white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.
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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064.
{1}------------------------------------------------
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, white(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 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 | Meets |
| and D6124-01 | <2mg/glove | |
| Biocompatability | Primary Skin Irritation inrabbits | PassesNot a Primary Skin Irritation |
| Dermal sensitization in theguinea 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 .
Powder free vinyl pation examination gloves , white(non-colored) meet requirements per ASTM D5250-0064, pdr 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.
[{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 meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., mect labeling claims .
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus in the logo is composed of three abstract human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zibo Sinocare Plastic Products Company Limited C/O Mr. Chu Xiaoan 209 Bei Si Huan Zhong Road Haidian District, Building 1, Beijing, CHINA 100083
Re: K051148
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, White (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 6, 2005 Received: May 4, 2005
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.
JUN 2 1 2005
{3}------------------------------------------------
Page 2 - Mr. Xiaoan
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be actived that 22 a determination that your device complies with other requirements moan that I Dr mas made statutes and regulations administered by other Federal agencies. or the Act of any 1 ederal banks as a requirements, including, but not limited to: registration r ou intist comply wart 807); labeling (21 CFR Part 801); good manufacturing practice and noung (21 cm ) in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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) I mis letter will and in Jorly For Station of substantial equivalence of your device to a premarket notification of 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), 11 Jou donto 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 may 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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Powder Free Vinyl Patient Examination Gloves, White (non-colored)
Indications For Use: Powder free vinyl patient examination glove is a disposable indications i or Osc. T owder noo may parties worn on the examiner's hand or device intended for mountal por 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)
Shuler 12 Murphy MD 2/24/05
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K231148
§ 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.