(52 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.
Acceptance Criteria and Study for Powder Free Vinyl Patient Examination Gloves
This device is a Class I medical device and does not require a complex clinical study for approval. The submission relies on non-clinical testing and adherence to established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (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 and D6124-01 | <2mg/glove |
| Biocompatibility (Primary Skin Irritation) | ISO10993-10 (via Primary Skin Irritation in rabbits) | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | ISO10993-10 (via Dermal sensitization in the 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 specific sample sizes used for each individual test (e.g., number of gloves tested for pinholes, or number of animals for biocompatibility). However, the tests are conducted in accordance with the referenced ASTM and ISO standards, which would define appropriate sample sizes for these types of assessments.
- Data Provenance: The device manufacturer is SHIJIAZHUANG BENESTAR PLASTIC CO., LTD. located in CHINA. The testing was conducted to meet international standards (ASTM and ISO) and US regulations (21 CFR).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Ground Truth Establishment: For this type of device and testing, "ground truth" is established by adherence to standardized testing protocols and objective measurements outlined in the referenced ASTM standards, 21 CFR, and ISO standard. There is no mention of human experts establishing ground truth for the test set beyond the qualified personnel performing the standardized laboratory tests.
- Qualifications of Experts: The document does not specify the qualifications of the individuals who performed the tests. It is assumed that these tests were conducted by trained technicians in laboratories accredited to perform such work in accordance with the respective standards.
4. Adjudication Method for the Test Set
Not applicable. The performance is assessed against objective, measurable criteria defined by the referenced standards, not through human adjudication of subjective data. (e.g. 2+1, 3+1, none) for the test set.
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 typically relevant for interpretative devices (e.g., imaging software) where human interpretation is a key component. This device is a patient examination glove, and its effectiveness is determined by its physical properties and biocompatibility, not by human interpretation of its function.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the device. "Standalone" performance usually refers to the performance of an AI algorithm without human involvement in interpretation or decision-making. Since this device is a physical glove, not an algorithm, this question is not relevant. The device itself is "standalone" in its function as a barrier.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective measurements against established national and international standards. This includes:
- Physical measurements (e.g., dimensions)
- Mechanical property tests (e.g., tensile strength, elongation)
- Chemical residue analysis (powder residual)
- Barrier integrity tests (freedom from pinholes based on water leak AQL as per 21 CFR 800.20)
- Biocompatibility assessments based on animal models (primary skin irritation and dermal sensitization) as defined by ISO10993-10.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on its physical and biological properties.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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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: K 090691 (applicant leave blank) MAY
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 : | SHIJIAZHUANG BENESTAR PLASTIC CO., | |
|---|---|---|
| LTD. | ||
| Submitter's address : | HELI, NANNIU TOWN, ZHENGDING | |
| COUNTY, HEBEI, 050000, CHINA | ||
| Phone number : | (86) 311-83985366 | |
| Fax number : | (86) 311-83986358 | |
| Name of contact person: | Mr. David QU | |
| Date the summary was prepared: | Mar. 3rd, 2009 |
[(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 free 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.
J(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 5250-06and D6124-01 | <2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbits | PassesNot a Primary Skin Irritation |
| Dermal sensitization in the guinea 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 .
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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle, indicating the department's name and national affiliation.
MAY - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chu Xiaoan Official Correspondent Shijiazhuang Benestar Plastic Company, Limited Room 1606 Bulding, 1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District, Beijing 100083, P.R. China
Re: K090691
Trade/Device Name: Poder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 880.6250 Regulatory Class: I Product Code: LYZ Dated: March 3, 2009 Received: March 16, 2009
Dear Mr. Xiaoan:
We have reviewed your Scetion 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 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); 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. Xiaoan
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) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 Runner
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: SHIJIAZHUANG BENESTAR PLASTIC 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)
Shule Mighy R
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090691
§ 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.