(32 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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-004
Here's a breakdown of the acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)" 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 5250-00d | Meets |
| Physical Properties | ASTM standard D 5250-00d | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00d | Meets (<10mg/dm²) |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to meeting standards without detailing the number of units tested for each characteristic.
- Data Provenance: Not explicitly stated. The studies are described as "nonclinical" and likely conducted in a laboratory setting, but the country of origin of the data is not specified. It's implicitly from the manufacturer, JIANGSU CUREGUARD GLOVE CO., LTD.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device is based on objective measurements against established industry standards (ASTM, CFR, ISO) rather than expert consensus on subjective interpretations.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement among experts. Here, the tests involve objective measurements against predefined limits.
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 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 not an algorithm or AI system.
7. The type of ground truth used:
- The ground truth used is based on objective measurements conforming to recognized standards (e.g., ASTM standard D 5250-00d for dimensions, physical properties, and powder amount; 21 CFR 800.20 for freedom from pinholes; ISO10993-10 for biocompatibility).
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The assessment is based on physical and biological testing against established specifications.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set involved for this type of device. The "ground truth" for ensuring compliance is established by the referenced standards themselves and the methods described within those standards for testing.
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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."
"The assigned 510(k) number is: K07 0075" (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 : | JIANGSU CUREGUARD GLOVE CO., LTD. |
|---|---|
| Submitter's address : | NO. 205 JIANLING ROAD, THE ECONOMICDEVELOPMENT ZONE OF SUQIAN CITY, JIANGSU223800 CHINA |
| Phone number : | (86) 0527-4568102 |
| Fax number : | (86) 0527-4568100 |
| Name of contact person: | Mr.Zhang Bohoo |
| Date the summary was prepared: | Jan.02,2007 |
[(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 Gloves,Clear (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: | 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* powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.
[(a)(4)] A description of the device
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Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-004
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered 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 powdered vinyl patient examination gloves, Clear (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 5250-00d | Meets |
| Physical Properties | ASTM standard D 5250-00d | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00d | Meets |
| Biocompatability | Primary Skin Irritation inrabbits | <10mg/dm² |
| Passes | ||
| Dermal sensitization in theguinea pig | Not a Primary Skin Irritation | |
| 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 .
Powdered vinyl patient examination gloves , Clear(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 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 Powdered Vinyl Patient Examination Gloves, Clear(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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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jiangsu Cureguard Glove Company Limited C/O Mr. Chu Xiaoan Beijing Ease-Link Company Room 1606, Building 1, Jianxiang Yuan No. 209, Bei Si Huan Zhong Road Haidian District, Beijing100083, P.R. CHINA
9 2007 FFB
Re: K070075
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 2, 2007 Received: January 8, 2007
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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Page 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 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 (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 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 yours,
Susan Runne
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:_JIANGSU CUREGUARD GLOVE CO., LTD.,
K070075 510(k) Number (if known): *
Device Name: Powdered Vinyl Patient Examination Gloves, Clear(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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Murphy, RO 2/4/07
§ 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.