(27 days)
Powder Free Vinyl Patient Examination Gloves, 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.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)":
This is a 510(k) summary for medical gloves, which are low-risk devices. As such, the "study" demonstrating the device meets acceptance criteria is primarily based on non-clinical performance testing against established standards, rather than a complex clinical trial.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimension: ASTM standard D 5250-06 e1 | Meets |
| Physical Properties: ASTM standard D 5250-06 e1 | Meets |
| Freedom from pinholes: 21 CFR 800.20 | Meets |
| Powder Residual: ASTM standard D 5250-06 e1 and D6124-06 | Meets (<2mg/glove) |
| Biocompatibility - Primary Skin Irritation: AAMI / ANSI / ISO 10993-10 | Passes (Not a Primary Skin Irritation) |
| Biocompatibility - Dermal Sensitization: AAMI / ANSI / ISO 10993-10 | Passes (Not a Dermal Sensitization) |
Study Details
The "study" in this context refers to a series of non-clinical tests performed to demonstrate compliance with recognized standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided summary. For these types of tests, sample sizes are typically defined by the specific ASTM and ISO standards (e.g., a certain number of gloves per batch for tensile strength, or a specific number of animals for biocompatibility tests).
- Data Provenance: The tests were conducted according to recognized international and US standards (ASTM, 21 CFR, AAMI / ANSI / ISO 10993-10). The location where the actual testing was performed is not specified, but it would have been in a certified laboratory. The nature of these tests is always prospective for the device being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in the traditional sense of clinical studies. The "ground truth" for these tests is defined by the specifications and methodologies outlined in the referenced standards (ASTM, 21 CFR, ISO).
- Qualifications of Experts: The "experts" are the technical committees and bodies responsible for developing and maintaining these international and national standards. The actual testing would be performed by qualified laboratory technicians and scientists following the standard operating procedures defined by the standards. For biocompatibility, qualified toxicologists/pathologists would interpret results.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. The "adjudication" is inherent in the pass/fail criteria defined by the respective standards. There is no subjective interpretation requiring multiple experts to reach a consensus. The results are quantitative and compared directly to predefined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved and needs to be compared with or without AI assistance. For patient examination gloves, such a study would not be appropriate or necessary.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical medical device (gloves), not an algorithm or AI system.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth is established by international and national standards and regulations (ASTM standard D 5250-06 e1, ASTM D6124-06, 21 CFR 800.20, AAMI / ANSI / ISO 10993-10). These standards define the acceptable physical properties, safety parameters, and test methods for patient examination gloves.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set. The device is evaluated directly against pre-defined performance standards.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this device type.
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Section C 510(k) Summary (21 CFR 807.92)
APR 22 2010
510(K) 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: ______________________________________________________________________________________________________________________________________________ " (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 : | Suzhou Shengyuda Plastic Products Co.,Ltd. |
|---|---|
| Submitter's address : | Zhitang Industrial Park,Zhitang Town Changshu CityJiangsu Province,215531,China |
| Phone number : | 86-512-52553368 |
| Fax number : | 86-512-52515875 |
| Name of contact person: | Ms.Chen Su |
| Date the summary was prepared: | Mar.10, 2010 |
[(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:
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Powder Free Vinyl Patient Examination Gloves. Clear (non-colored)
Proprietary/Trade name:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Other clients private labeling
Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Exam gloves Patient examination glove I 21 CFR 880.6250 General Hospital (80) 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 5250-06e1.
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Predicate device: FUGUAN (Brand) Powder-Free Viny) 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 5250-06e1.
[(a)(5)} The summary describes the intended use of the device
Device Intended Use: Powder Free Vinyl Patient Examination Gloves, 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, 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 5250-06 el. | Meets |
| Physical Properties | ASTM standard D 5250-06 el. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1and D6124-06 | Meets<2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbitsAAMI / ANSI / ISO 10993-10 | PassesNot a Primary Skin Irritation |
| Dermal sensitization in the guinea pigAAMI / ANSI / ISO 10993-10 | 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 .
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002.
[(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, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AOL., meet labeling claims,
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd., K032908
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
APR 2 2 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Suzhou Shengyuda Plastic Products Company, Limited C/O Mr. Chu Xiaoan Official Correspondent Beijing Easy - Link Company, Limited Room 1606 Building, 1 Jian Xiang Yuan No. 209 Bei Beijing China 100083
Re: K100855
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: March 19, 2010 Received: March 26, 2010
Dear Mr. Chu 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.34If 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. Chu 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: registrationand 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 (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.
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 vours.
Nh fur
Anthony D. Watson, BS, MS, MBA 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: Suzhou Shengyuda Plastic Products Co.,Ltd.
510(k) Number (if known): *
Device Name:
Indications For Use:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
k 100 855 510(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.