(110 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.
This is a summary of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets standard | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets standard | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets standard (likely AQL for waterleak test) | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-01 | < 2mg/glove | < 2mg/glove |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation in rabbits | Fails to produce primary skin irritation | Passes (Not a Primary Skin Irritation) |
| Biocompatibility: Dermal Sensitization | Dermal sensitization in the guinea pig | Fails to produce dermal sensitization | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test in the "test set". However, the tests are conducted in accordance with the cited ASTM and CFR standards, which would specify appropriate sample sizes.
Data Provenance: The data provenance is not explicitly stated in terms of country of origin but is based on non-clinical laboratory testing (e.g., in vitro, animal studies for biocompatibility) and adherence to international and national standards (ASTM, CFR). The testing is retrospective in the sense that completed tests are submitted, but the source of the materials tested would be the manufacturer's products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device does not involve a scenario where human experts establish ground truth for a test set in the way a diagnostic imaging device would. The "ground truth" here is defined by the objective pass/fail criteria of the specified ASTM and CFR standards for physical properties and biocompatibility. The "experts" would be the accredited laboratories and personnel conducting these standardized tests. Their qualifications would involve expertise in materials testing, chemistry, and toxicology, following good laboratory practices (GLP) to ensure the validity and reliability of the results against the defined standards.
4. Adjudication method for the test set
Not applicable. The tests are based on objective measurements and predefined pass/fail criteria from recognized standards. There isn't a need for expert adjudication in the context of image interpretation or subjective assessments.
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 physical medical device (examination glove), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device.
7. The type of ground truth used
The ground truth used for this device's performance evaluation is based on objective standards and regulatory requirements. Specifically:
- ASTM standards (D 5250-06, D6124-01) for dimensions, physical properties, and powder residual.
- 21 CFR 800.20 for freedom from pinholes (waterleak test).
- ISO 10993-10 (referenced for biocompatibility testing, specifically primary skin irritation and dermal sensitization).
These standards define the acceptable range or threshold for each characteristic.
8. The sample size for the training set
Not applicable. This device is a physical medical device. The concepts of "training set" and "ground truth for training set" are relevant to machine learning or AI models, not to the premarket notification of a patient examination glove. The manufacturer's production process would involve quality control and specification adherence, but not a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not applicable (as explained in point 8).
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SEP 3 0 2008 Summary
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"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: ______________________________________________________________________________________________________________________________________________
Premarket Notification [510(k)] Summary
1(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 : | JIANGSU ALFA GLOVE CO., LTD. |
|---|---|
| Submitter's address : | Room 502,Flat 10,TianxingGarden, Suqian, Jiangsu, China, 223800 |
| Phone number : | (86) 0527--88286002 |
| Fax number : | (86) 0527- 88286000 |
| Name of contact person: | Ms. Zhang Hongyun |
| Date the summary was prepared: | May.26.2008 |
[(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 frec 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 |
| and D6124-01 | <2mg/glove | |
| Biocompatability | Primary Skin Irritation inrabbits | Passes |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in theguinea 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 , Clear(non-colored) meet requirements per ASTM D5250-06, 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 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 features a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
SEP 3 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jiangsu Alfa Glove Company, Limited C/o Mr. Chu Xiaoan Official Correspondent Beijing Easy-Link Company, Limited Room 1606, Building .1. Jianxiang Yuan No. 209, Beisi Huan Zhong Road, Hai Dian District, Beijing CHINA 100083
Re: K081658
Trade/Device Name: Powder Free Vinyl Patient Examination Goves, Clear (Non-colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 11, 2008 Received: September 17, 2008
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.
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Pagc 2 – Mr. 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 complics 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Clive Seligman, Ph.D.
Chiu S. Lin. Ph. D Division 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:_JIANGSU ALFA GLOVE 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 (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)
Shiela A Murphy B
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081658
§ 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.