(14 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 5250-0004
This is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. The information provided is standard for this type of device and does not involve complex AI algorithms or detailed clinical studies in the way you might expect for an AI-powered diagnostic tool. Therefore, many of your requested items, such as expert adjudication, MRMC studies, and detailed training set information, are not applicable in this context.
Here's an analysis based on the provided document:
1- A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00c4 | <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes |
| Dermal sensitization in the guinea pig | Passes |
2- Sample size used for the test set and the data provenance
The document indicates that the device meets the specified ASTM standards and FDA regulations, which involve testing batches of gloves to ensure compliance. However, it does not specify explicit sample sizes for the "test set" in the context of a software or AI device. The testing related to manufacturing quality (pinholes, dimensions, physical properties, powder residual) is typically done on a statistically representative sample from each production lot, as per the respective standards (e.g., AQL levels for pinholes).
- Sample Size: Not explicitly stated for each test, but implied to be statistically significant samples as required by the referenced ASTM standards and 21 CFR 800.20 for manufacturing quality control.
- Data Provenance: The tests are conducted by the manufacturer, HEBEI MANFUL IMPORT & EXPORT CO., LTD, presumably in their facilities in P.R. CHINA, to demonstrate compliance with US standards (ASTM, FDA). This is a prospective evaluation of manufactured product batches.
3- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of examination glove does not involve expert interpretation or ground truth establishment in the way AI diagnostics do. The "ground truth" for these tests are objective measurements against established physical and chemical standards.
- Number of Experts: Not applicable. The "ground truth" is defined by the objective measurement criteria of the ASTM and FDA standards.
- Qualifications of Experts: Not applicable in the context of human interpretation. Quality control technicians, chemists, and engineers with expertise in materials testing perform the measurements.
4- Adjudication method for the test set
Not applicable. Testing involves objective measurements (e.g., tensile strength, elongation, physical dimensions, water leak test for pinholes, chemical analysis for powder residue, and biological assays for biocompatibility). There is no subjective interpretation requiring adjudication.
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 a physical device, not an AI-assisted diagnostic tool.
6- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device.
7- The type of ground truth used
The ground truth used for demonstrating compliance is based on:
- Objective Measurement Data: Physical dimensions, tensile strength, elongation, freedom from pinholes (water leak test AQL), and powder residual measured against an absolute standard.
- Biological Assay Results: Results from standardized in vivo tests for primary skin irritation and dermal sensitization, which are objective pass/fail criteria.
8- The sample size for the training set
Not applicable. There is no software or AI algorithm in this device that requires a training set.
9- How the ground truth for the training set was established
Not applicable. There is no software or AI algorithm in this device that requires a training set.
In summary: The provided document describes a medical device that undergoes quality control testing to meet established industry and regulatory standards. It is not an AI-powered device, so many of the questions asked in the prompt, which are typically relevant for AI/ML device evaluations, do not apply here. The "study" proving the device meets acceptance criteria refers to manufacturing quality control and biocompatibility testing against defined industry standards (ASTM) and FDA regulations.
{0}------------------------------------------------
C 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."
." (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 : | HEBEI MANFUL IMPORT & EXPORT CO., LTD | |
|---|---|---|
| Submitter's address : | NO.58 TONGDA ROAD, JINZHOU CITY, HEBEIPROVINCE, 052260, P.R.CHINA | |
| Phone number : | (86) 311-4338239 | |
| Fax number : | (86) 311-4338239 | |
| Name of contact person: | Ms. Yanchai Zhang | |
| 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 mecels 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 5250-0004
{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 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00c4 | Meets |
| Biocompatability | and D6124-01 | <2mg/glove |
| Primary Skin Irritation inrabbits | Passes | |
| Dermal sensitization in theguinea pig | Passes |
[(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 , white(non-colored) meet requirements per ASTM D5250-004, 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.
[(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., meet 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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2005
Ms. Yanchai Zhang General Manager Assistant Hebei Manful Import & Export Company Limited No. 58 Tongda Road Jinzhou City, Hebei Province, 052260 P.R. CHINA
Re: K051153
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, White (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 6, 2005 Received: May 4, 2005
Dear Ms. Zhang:
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 Amerade onts, 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 (1 Nr.), it may of bacyco 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.
{3}------------------------------------------------
Page 2 - Ms. Zhang
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements mean that I DA mas made statutes and regulations administered by other Federal agencies. of the riot of ally I outhal the Act's requirements, including, but not limited to: registration 1 ou intist comply with a807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT at 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quality ijon 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) This letter will and A 70 a be objact to and of substantial equivalence of your device to a premarket notification. - The PDF 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), 11 you desire specific acritic 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 overn built generational 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
Applicant: HEBEI MANFUL IMPORT & EXPORT CO., LTD
510(k) Number (if known): K051153
Device Name: Powder Free Vinyl Patient Examination Gloves, White(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 (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)
insion Sign-Off) resion of Anesthesiology, General Hospital, Inrection Control, Dental Devices
Number: K 051153
Image /page/4/Picture/14 description: The image shows a black and white picture of a blurry object. The object appears to be a cluster of small, dark spots against a white background. The spots are concentrated in the center-right of the image, with a few scattered spots towards the left. The overall impression is one of indistinctness and lack of clear detail.
§ 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.