(22 days)
Powdered 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.
powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4
The provided text describes the regulatory submission for Powdered Vinyl Patient Examination Gloves. It details the device's characteristics and its equivalence to a predicate device, primarily through adherence to established standards.
Here's an analysis of the acceptance criteria and the study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported 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 Amount | ASTM standard D 5250-00e4 | Meets |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes, Not a Primary Skin Irritation (<10mg/dm2) |
| Dermal sensitization in the guinea pig | Passes, Not a Dermal sensitization |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" sample size in the context of typical AI/software performance studies. The testing described pertains to physical and biological properties of the gloves, and the sample sizes for these tests are not explicitly stated. The data provenance is internal testing by the manufacturer, SHIJIAZHUANG WINFUL PLASTIC CO.,LTD, located in China. The studies are by nature retrospective as they are conducted on manufactured products to ensure compliance.
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 as the device is a physical medical device (examination gloves), not an AI/software device requiring expert interpretation of data to establish ground truth for a test set. The "ground truth" for the device's performance is objective measurements against established ASTM and CFR standards, as performed by laboratory testing.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3. No adjudication method is described for determining the "ground truth" of the physical and biological characteristics of the gloves.
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
This information is not applicable. The device is an examination glove, not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an examination glove, and there is no algorithm or human-in-the-loop involved in its function or evaluation.
7. The type of ground truth used
The ground truth used for evaluating the device is based on objective measurement against established regulatory and industry standards. Specifically:
- ASTM standard D 5250-00e4 for dimensions, physical properties, and powder amount.
- 21 CFR 800.20 for freedom from pinholes (waterleak test).
- ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal sensitization tests).
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this device, as it is a physical product and not an AI/machine learning model.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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C Summary
AN - 7 2005
"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: " (applicant leave blank)
Premarket Notification [510(k)} Summary
{{a){}}. 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 WINFUL PLASTIC CO.,LTD |
|---|---|
| Submitter's address : | NO.6 CANGSHI ROAD, JINZHOU CITY,HEBEI, 052260,P.R. China |
| Phone number : | ( 86)-311-4320503 |
| Fax number : | ( 86)-311-4336614 |
| Name of contact person: | Mr. Yin Mingfei |
| Date the summary was prepared: | Dec.06,2004 |
[(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: | Powdered Vinyl Patient Examination GlovesWhite (Non-colored) |
|---|---|
| Proprietary/Trade name: | Powdered Vinyl Patient Examination GlovesOther clients private labeling |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | 1 |
| 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* powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00t4
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd., K032907.
[(a)(4)] A description of the device
Device Description : powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4
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Device Intended Use: powdered 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 powdered vinyl patient examination gloves, white(non-colored) 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 Amount | ASTM standard D 5250-00e4 | Meets |
| Biocompatability | Primary Skin Irritation in rabbits | <10mg/dm2 |
| 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 .
Powdered vinyl patient examination gloves , white(non-colored) meet requirements per ASTM D5250-00-4, 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 Powdered Vinyl Patient Examination Gloves, White(non-colored) 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 is a seal for the Department of Health & Human Services - USA. The seal is circular and contains text around the perimeter. In the center of the seal is a stylized symbol that resembles an eagle or bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2005
Shijiazhuang Winful Plastic Company Limited C/O Ms. Chen Yuhong TUV Rheinland Beijing Office Unit 707, AVIC Building, No. 10B Central Road, East 3rd Ring Road, Chaoyang District, Beijing 100022, P.R. CHINA
Re: K043477
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, White (Non-Colored Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 13, 2004 Received: December 16, 2004
Dear Ms. 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 - Ms. 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. or the riet of arry voith 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) 594-0115. 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 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 yours,
Sutte Michael O for DR. CHIU LIN
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 WINFUL PLASTIC CO.,LTD
510(k) Number (if known):* KO43477
Device Name: Powdered Vinyl Patient Examination Gloves, White(Non-colored)
Indications For Use:
Powdered 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suste Michael MD
(Divisi
510(k) Number: K043477
§ 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.