(39 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.
The document discusses the regulatory submission for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" by TANGSHAN FUQIANG GLOVE CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device by meeting established standards for patient examination gloves.
Here's an analysis of the acceptance criteria and related study information based on the provided text:
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 D6124-06 | <2mg/glove |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | 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 test (e.g., for pinholes, physical properties, or biocompatibility). However, it implies that the tests were conducted according to the specified ASTM standards and CFR regulations, which would include defined sample size requirements within those standards.
- Provenance: The tests were conducted by the manufacturer, TANGSHAN FUQIANG GLOVE CO., LTD., which is based in Hebei Province, China. The testing itself is presented as non-clinical data, implying a retrospective analysis of manufacturing quality control and standard-driven testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The evaluations are based on meeting specified objective standards (ASTM, CFR), not on expert consensus for subjective interpretation.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple human readers. Since this submission relies on objective testing against established engineering and biological standards for a Class I general purpose device (patient examination gloves), an adjudication method is not applicable and therefore not mentioned. The "ground truth" is determined by whether the device's physical and biological characteristics meet the specified thresholds in the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. Patient examination gloves are a Class I device with clear objective performance criteria, not requiring human interpretation of clinical cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable. The device is a physical product (patient examination glove), not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant. The device's "standalone" performance is its ability to meet the defined physical and biological standards.
7. Type of Ground Truth Used
The ground truth used for this device is based on established industry standards and regulatory requirements:
- ASTM standard D 5250-06: For dimensions and physical properties.
- ASTM standard D 6124-06: For powder residual.
- 21 CFR 800.20: For freedom from pinholes (waterleak test AQL).
- ISO10993-10 (implied basis for biocompatibility tests): For primary skin irritation and dermal sensitization.
8. Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of a physical medical device like a glove. Training sets are typically used for machine learning algorithms. The manufacturer conducts quality control and testing on production batches to ensure consistency with the standards.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as point 8. The "ground truth" for compliance testing is defined by the objective metrics and thresholds within the cited ASTM and CFR standards.
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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: ______________________________________________________________________________________________________________________________________________
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Premarket Notification [510(k)] Summary
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[(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 : | TANGSHAN FUQIANG GLOVE CO., LTD. |
|---|---|
| Submitter's address : | TANGLE ROAD, LUANNAN COUNTY, TANGSHAN CITY,HEBEI PROVINCE, 063500, CHINA |
| Phone number : | (86) 315-4169201 |
| Fax number : | (86) 315-4169311 |
| Name of contact person: | Mr. Zhang Liang |
| Date the summary was prepared: | Jan 10nd 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: | 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
Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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[(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.
[(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 |
| and D6124-06 | <2mg/glove | |
| Biocompatability | Primary Skin Irritation inrabbits | Passes |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in theguinea pig | Passes | |
| Not 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 D6124-06, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract design of three overlapping human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the seal in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tangshan Fuqiang Glove Company, Limited C/O Mr. Chu Xiaoan Room 1606 Building 1 Jianxiang Yuan No. 209 Bei Si Beijing China 100083
OCT 4 2010
Re: K102431
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 24, 2010 Received: August 26, 2010
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. 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.
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 (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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., B.S., M.B.A. 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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K10243|
INDICATIONS FOR USE
Applicant: TANGSHAN FUQIANG GLOVE 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
K102431 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.