(64 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 5250-00e4
The provided document refers to the 510(k) summary for "FUGUAN (Brand) Powder Free Vinyl Patient Examination Gloves". This is a medical device application for gloves, not a complex AI-powered diagnostic or therapeutic device. As such, the study design and acceptance criteria are focused on physical and biological properties of the gloves, rather than diagnostic performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) or human-AI interaction in a clinical setting.
Therefore, the requested information categories typically applicable to AI/ML device studies (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not relevant to this specific product.
Here's a breakdown of the acceptance criteria and performance as described in the document, tailored to the nature of this device:
Acceptance Criteria and Device Performance for FUGUAN Powder Free Vinyl Patient Examination Gloves
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| Dimension | ASTM standard D 5250-00e4. | Meets |
| Physical Properties | ASTM standard D 5250-00e4. | Meets |
| Barrier Integrity | ||
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Chemical Properties | ||
| Powder Residual | ASTM standard D 5250-00e4 | <2mg/glove |
| Biocompatibility | (Not explicitly stated as a numerical standard in table, but referenced in narrative) | |
| Primary Skin Irritation | (Implied by standard testing, ISO10993-10 mentioned) | Passes (Not a Primary Skin Irritation) |
| Dermal Sensitization | (Implied by standard testing, ISO10993-10 mentioned) | Passes (Not a Dermal Sensitization) |
Study Details:
- Sample size used for the test set and the data provenance: The document does not specify a distinct "test set" in the context of an AI/ML study. The evaluation appears to be based on quality control testing of representative samples of the manufactured gloves for each characteristic. No specific sample sizes for these tests are provided in this summary. Data provenance is implied by the manufacturer's location (Shijiazhuang Fuguan Plastic Products Co., Ltd., China) and adherence to international standards (e.g., ASTM, ISO) and US regulations (e.g., 21 CFR). The testing is generally prospective, as it involves evaluating manufactured products against predetermined standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of devices is established by objective measurements against recognized industry standards (e.g., ASTM for physical properties, 21 CFR for pinholes, ISO for biocompatibility). Human expert consensus is not a factor for these objective measures.
- Adjudication method for the test set: Not applicable. The "ground truth" is determined by direct measurement and adherence to established pass/fail criteria from the standards.
- 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 patient examination glove, not an AI-powered diagnostic tool requiring human reader studies.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical product, not an algorithm.
- The type of ground truth used:
- Objective Standards: The "ground truth" is established by publicly available and internationally recognized technical standards and regulations:
- ASTM standard D 5250-00e4 (for dimensions, physical properties, powder residual)
- 21 CFR 800.20 (for freedom from pinholes/waterleak test)
- ASTM D6124-01 (implied for powder residual measurement)
- ISO10993-10 (for biocompatibility, specifically irritation and sensitization)
- Objective Standards: The "ground truth" is established by publicly available and internationally recognized technical standards and regulations:
- The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/ML device. Manufacturing processes are optimized through engineering and quality control, not machine learning training.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The study demonstrating the device meets the acceptance criteria is a series of non-clinical bench tests and biocompatibility assessments. These tests are performed on samples of the manufactured gloves to ensure they conform to established safety and performance standards. The conclusions are drawn from these non-clinical tests, affirming that the FUGUAN (Brand) Powder Free Vinyl Patient Examination Gloves meet the requirements of ASTM standard D 5250-00e4, ASTM D6124-01, 21 CFR 800.20, and ISO10993-10. This substantiates that the device is as safe and effective as the predicate device (Shijiazhuang Great Eagle Plastics Products Co., Ltd. K000071). Clinical data was deemed not necessary for this type of device.
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510(k) 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."
NOV 2 0 2003
"The assigned 510(k) number is: 032908 ." (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 : | Shijiazhuang Fuguan Plastic Products Co., Ltd. | |
|---|---|---|
| Submitter's address : | The Jia Village, Dahe County, Lu Quan City, Hebei Province,050204 P.R.China | |
| Phone number : | (86) 311 229 4202 | |
| Fax number : | (86) 311 229 1575 | |
| Name of contact person: | Chun-jing AN | |
| Date the summary was prepared: | 12 September 2003 |
[(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: | FUGUAN (Brand) 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 : synthetic powder-free (white ) vinyl patient examination glove, Shijiazhuang Great Eagle Plastics Products Co., Ltd. K000071 .
[(a)(4)] A description of the device
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Device Description : powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, white(nonis a disposable device intended for medical purposes that is worn on the examiner's colored) 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 |
| Biocompatability | <2mg/glove | |
| Primary Skin Irritation in rabbits | Passes | |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in the guinea pig | Passes | |
| 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 , white(non-colored) meet requirements per ASTM D5250-0064, 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 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 FUGUAN (Brand) 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Shijiazhuang Fuguan Plastic Products Company Limited C/O Mr. Chen Yuhong TUV Rheinland Beijing Office RM. 707, AVIC Bldg No.2 Dong San Huan Nan Road Chaoyang District Beijing, 100022, P.R. China
Re: K032908
Trade/Device Name: Fuguan (Brand) 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: September 12, 2003 Received: September 24, 2003
Dear Mr. Yuhong:
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.
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Page 2 - Mr. Yuhong
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (301) 594-4618. 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 Division 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/dsma/dsmamain.html
Sincerely vours.
Susan Luna
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
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INDICATIONS FOR USE
Applicant: Shijiazhuang Fuguan Plastic Products Co., Ltd ..
14032908 510(k) Number (if known): *
Fuguan 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 807 Subpart C) X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susanne F. Bamer
sion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K032908
§ 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.