(69 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, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
The provided text describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves (Light Yellow)." This is a medical device submission, specifically for patient examination gloves, which are low-risk devices. Therefore, the acceptance criteria and study design are different from what would be expected for a complex AI/ML diagnostic or prognostic device.
Here's the breakdown of the information based on your request, tailored to this type of device:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Reported 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 Amount | ASTM standard D 5250-06 | < 10 mg/dm² |
| Biocompatibility: | ||
| --> Primary Skin Irritation | Per ISO10993-10 or equivalent (rabbits) | Passes; Not a Primary Skin Irritation |
| --> Dermal Sensitization | Per ISO10993-10 or equivalent (guinea pig) | Passes; Not a Dermal sensitization |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for pinholes, how many animals for biocompatibility). However, the tests are conducted according to established standards (ASTM, FDA regulations, ISO), which inherently define the sampling methods and acceptance levels.
- Provenance: This is a physical product (gloves), not data in the sense of patient records or images. The "data" provenance refers to the testing conducted on the manufactured gloves. There is no mention of country of origin for the data (testing results), but the manufacturer is based in China. The tests are non-clinical and would be considered prospective for the specific batch of gloves tested to support the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this device. "Ground truth" usually refers to diagnostic accuracy in complex medical imaging or clinical decision-making. For these gloves, "ground truth" is established by direct measurement against a defined engineering or biological standard. For example, a pinhole is objectively present or absent based on a waterleak test. Biocompatibility tests are performed by trained laboratory personnel following established protocols, not by "experts" establishing a subjective ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. The tests are objective measurements against defined criteria (e.g., glove dimensions, force at break, waterleak test for pinholes, standardized biological assays). There is no subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. MRMC studies are used for evaluating diagnostic performance of imaging devices or algorithms with human readers. This device is a medical glove, not a diagnostic tool requiring interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The "ground truth" for the acceptance criteria is defined by industry standards (ASTM D 5250-06, ASTM D6124-01) and regulatory requirements (21 CFR 800.20, ISO10993-10). This includes:
- Engineering specifications: For dimensions, physical properties (tensile strength, elongation), and powder amount.
- Physical test results: For freedom from pinholes (waterleak test).
- Biological assay results: For biocompatibility (primary skin irritation and dermal sensitization tests in animal models).
8. The Sample Size for the Training Set:
- Not applicable. This is a manufactured product, without a "training set" in the AI/ML sense. The manufacturing process uses quality control, and the design itself is based on general engineering principles for glove production, not machine learning.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for this device. The design specifications and manufacturing process are established based on the requirements of the ASTM standards and FDA regulations, informed by decades of glove manufacturing and material science.
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Summary
AUG 20 2008 "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: K08) 657 - . " (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: | 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: | Powdered Vinyl Patient Examination Gloves, (Light Yellow) |
|---|---|
| Proprietary/Trade name: | Rubber -Like |
| 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, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : Powdered Vinyl Patient Examination Gloves, JIANGSU CUREGUARD GLOVE CO., LTD., K070075
[(a)(4)| A description of the device
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Device Description : powdered vinyl patient examination gloves, (Light Yellow) 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: powdered vinyl patient examination glove, (Light Yellow) is a disposable device intended for nedical 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,(Light Yellow)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 Amount | ASTM standard D 5250-06 | <10mg/dm² |
| Biocompatability | Primary Skin Irritation inrabbits | Passes |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in theguinea pig | 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 , (Light Yellow) 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 Powdered Vinyl Patient Examination Gloves, (Light Yellow) 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 and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 2008
Jiangsu Cureguard Glove Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company Room 1606 Building 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District, Beijing 100083, P.R. China
Rc: K081657
Trade/Device Name: Powdered Vinyl Patient Examination Gloves (Light Yellow) Regulation Number: 878.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 26, 2008 Reccived: June 12, 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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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 vour 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
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.,
510(k) Number (if known): * K 081657
Device Name:_Powdered Vinyl Patient Examination Gloves (Light Yellow)
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 _**_ AND/OR Over-The-Counter Use X
(Part 21 CFR 801 Subpart D) (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)
Shule Murphy PB
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081657
§ 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.