(379 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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific points:
Acceptance Criteria and Device Performance
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 Residual | ASTM standard D 5250-06 and D6124-01 | < 2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes |
| Dermal sensitization in the guinea pig | Passes (Not a Dermal sensitization, Not a Primary Skin Irritation) |
Notes:
- The device being evaluated is "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)".
- The primary standards for acceptance are ASTM D 5250-06, 21 CFR 800.20, and ASTM D6124-01. In the biocompatibility section, ISO 10993-10 is also referenced as a requirement met, and the specific tests mentioned (Primary Skin Irritation, Dermal sensitization) are typically part of biocompatibility assessments within such standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It only states that the device "meets" the requirements of the standards listed. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective/prospective. The manufacturer is from Tangshan, P.R. China, so it's possible testing occurred there.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Given this is a 510(k) submission for medical gloves, "ground truth" in the context of expert review (like for diagnostic imaging AI) is not applicable. The assessment relies on laboratory testing against established physical and chemical standards, as well as biocompatibility tests. No human experts are described as establishing ground truth in this manner.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The evaluation is based on objective laboratory measurements and adherence to specified performance standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where reader performance is a key metric, often for AI-assisted interpretation. Medical gloves are not diagnostic devices, and their evaluation does not involve such studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Again, this concept is not applicable to a medical glove. Standalone performance and human-in-the-loop performance are terms used for AI algorithms. The device is a physical product, and its "performance" is measured directly against physical, chemical, and biological standards.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily objective laboratory measurements and tests against established consensus standards (ASTM, CFR, ISO). These standards define acceptable ranges or outcomes for various physical properties (e.g., dimensions, tensile strength, elongation), freedom from defects (pinholes), chemical residues (powder), and biological reactions (irritation, sensitization). This is a form of empirical validation against predefined metrics.
8. The Sample Size for the Training Set
Not applicable. Medical gloves do not utilize a "training set" in the context of machine learning or AI algorithms. The product undergoes manufacturing and quality control processes to ensure it meets specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device type.
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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: KOB2649." (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 :
| Submitter's name : | Tangshan Dar Plastic & Rubber Products Co., Ltd. |
|---|---|
| Submitter's address : | Tangshan Sanxin High tech Industrial estate,Tanggu Road, Tangshan city, Hebei province,063100, P.R.China |
| Phone number : | (86) 315-5028910 |
| Fax number : | (86) 315-5028929 |
| Name of contact person: | Mr. Wang Jincheng |
| Date the summary was prepared: | Sept. 04. 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
Sept. 04, 2008
| 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: | LV7 |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming
substantial equivalence 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 free vinyl patient examination glove, Clear(non-colored) is a disposable device intended for medical purposes that is worn on the examined) is a
prevent contemination bet 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 |
| Biocompatability | and D6124-01 | <2mg/glove |
| Primary Skin Irritation inrabbits | Passes | |
| Dermal sensitization in theguinea pig | PassesNot a Dermal sensitizationNot a Primary Skin Irritation |
[(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 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 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/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it.
Food and Drug Administration 10903 New Hampshire Avenne Document Mail Cemer - WO66-G609 Silver Spring, MD 20993-0002
Tangshan Dar Plastic & Rubber Products Company, Limited C/O Mr. Chu Xiaoan Chu Xiaoan Room 1606 Building 1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing 100083 CHINA
SEP 2 5 2009
Re: K082648
Trade/Device Name: Powder Free 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: August 19, 2009
Received: August.24, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D; amester by
Susan Runner, D.D.S., M.A. Acting 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: Tangshan Dar Plastic & Rubber Products Co., Ltd.
510(k) Number (if known): * K 08 2649
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)
Dalip Ganguli
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.