(66 days)
Powder Free Vinyl Patient Examination Gloves, Colored (White) 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, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.
This 510(k) summary describes the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves, Colored (White) marketed by TANGSHAN HENGDA PLASTIC PRODUCTS CO.,LTD.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (from 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 in rabbits (ISO10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig (ISO10993-10) | 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. However, it indicates that the device "meets" the requirements of the specified ASTM standards and 21 CFR 800.20, which would imply that the sample sizes used for those tests were compliant with the respective standards. The data provenance is implied to be from laboratory testing conducted on the manufacturer's gloves to demonstrate compliance with the referenced standards. No specific country of origin for the data is mentioned, but the manufacturer is based in China. The data is retrospective, as it pertains to the evaluation of the finished product.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The product is a medical device (examination gloves) and the "ground truth" is established by performance metrics defined in regulatory standards (ASTM, FDA CFR) rather than expert interpretation of medical images or data. The "experts" in this context would be the technicians and scientists performing the tests according to the standard protocols. Their specific number and qualifications are not detailed in the summary but are assumed to be appropriate for conducting the tests against the established standards.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation (e.g., radiologists reviewing images) where there might be disagreement. For mechanical and biological performance testing of examination gloves, the outcome is determined by adherence to quantifiable metrics within the specified standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging or similar scenarios. As this device is an examination glove, such a study is not applicable.
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not done. This device is a physical product (examination gloves), not an algorithm or AI system. Therefore, the concept of "standalone performance" in that context is not applicable. The performance described here is the inherent physical and biocompatibility performance of the gloves themselves.
7. Type of Ground Truth Used:
The ground truth used is primarily established through regulatory standards and specifications. This includes:
- ASTM standard D 5250-06: for Dimension and Physical Properties.
- 21 CFR 800.20: for Freedom from pinholes (waterleak test/AQL).
- ASTM standard D 6124-06: for Powder Residual.
- ISO10993-10: for Biocompatibility (Primary Skin Irritation and Dermal sensitization).
These standards define the acceptable performance parameters that the device must meet.
8. Sample Size for the Training Set:
This information is not applicable. Training sets are used for machine learning algorithms. This device is a physical product, not an AI or algorithm, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for this device.
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510 (K) Summary
NOV 1 2 2010
"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: ______________________________________________________________________________________________________________________________________________
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 : | TANGSHAN HENGDA PLASTIC PRODUCTSCO.,LTD. | |
|---|---|---|
| Submitter's address : | NORTH ROAD, LUANNAN COUNTY,TANGSHAN CITY , HEBEI PROVINCE, 063500,CHINA | |
| Phone number : | (86) 315-4169201 | |
| Fax number : | (86) 315-4169311 | |
| Name of contact person: | Mr. Fred Zhang | |
| Date the summary was prepared: | Aug 10th, 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, Colored (White) |
|---|---|
| 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, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : Powder free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD.,K051156 .
[(a)(4)] A description of the device
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Device Description : powder free vinyl patient examination gloves, Colored (White) 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, Colored (White) 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 5250-06and D6124-06 | <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 , Colored (White) 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 . ore
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/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tangshan Hengda Plastic Products Company Limited C/O Mr. Chu Xiaoan Official Correspondent Room 1606 Building . 1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District, Beijing 100083 China 100083
NOV 1 2 2010
Re: K102558
Trade/Device Name: Powder Free Vinyl patient Examination Gloves, Colored (White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 25, 2010 Received: October 27, 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 Pari 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 vours.
Sincerely yours,
for
Anthony D. Watson, B.S., M.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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INDICATIONS FOR USE
Applicant: TANGSHAN HENGDA PLASTIC PRODUCTS CO.,LTD.
NOV 1 2 2010
510(k) Number (if known): *
Device Name:_Powder Free Vinyl Patient Examination Gloves, Colored (White)
Indications For Use:
Powder Free Vinyl Patient Examination Gloves, Colored (White)__ 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)
Elizabeth S. Clavie-Wilber
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102558
§ 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.