(56 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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow):
Acceptance Criteria and Device Performance Study
The information provided describes the non-clinical testing performed to establish substantial equivalence for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties (e.g., tensile strength, elongation) | ASTM standard D 5250-06 | Meets |
| Freedom from Pinhole | 21 CFR 800.20 (Water Leak Test AQL) | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | < 2mg/glove |
| Biocompatibility | ||
| Primary Skin Irritation | Primary Skin Irritation in rabbits (ISO 10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal Sensitization | Dermal sensitization in the guinea pig (ISO 10993-10) | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for pinholes, physical properties, or for biocompatibility studies).
- Test Set Sample Size: Not explicitly stated. The standards (ASTM D5250-06, 21 CFR 800.20, D6124-06, ISO 10993-10) define statistical sampling plans, but the specific number of units tested in this submission is not provided in the summary.
- Data Provenance: The studies are non-clinical, likely performed by the manufacturer or a contract research organization (CRO) in China, given the submitter's address. The data is retrospective in the sense that the testing was performed, and the results are being submitted for regulatory review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is generally not applicable to the non-clinical testing of patient examination gloves. The "ground truth" is established by adherence to standardized testing protocols and measurement methodologies defined by the cited ASTM and CFR standards, not by expert consensus on subjective findings.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly when interpreting subjective outputs like medical images. For the non-clinical tests described for these gloves, the results are objective measurements (e.g., pass/fail for pinholes, numerical values for powder residual, observed biological reactions) and do not involve an adjudication process. The determination of "meets" or "passes" is based on comparing the measured outcome to the predefined threshold in the standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. These studies are relevant for devices involving interpretation by multiple human readers (e.g., radiologists, pathologists) and assessing the impact of a device (like AI) on their performance. This device is a disposable medical glove, and its performance is evaluated through standardized physical and biological testing, not by human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to this device. "Standalone performance" refers to the performance of an algorithm or AI system without human intervention. This device is a physical medical product (a glove), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is defined by the objective performance criteria specified in the referenced industry standards and regulations:
- Physical Properties: Defined by ASTM standard D 5250-06 (e.g., minimum tensile strength, elongation, dimensions).
- Freedom from Pinholes: Defined by 21 CFR 800.20 (Water Leak Test) with specific Acceptable Quality Limits (AQLs).
- Powder Residual: Defined by ASTM standard D 5250-06 and D6124-06 (maximum powder weight per glove).
- Biocompatibility: Defined by ISO 10993-10 (tests for primary skin irritation and dermal sensitization) with specific criteria for "passes" (e.g., minimal or no observed reaction).
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train machine learning models. This product is a physical medical device and does not involve machine learning or AI algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is 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: 11000 SB_ " (applicant leave blank)
$$\text{מאַטער } \text{-}, \text{5 2010}$$
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 ZHONGPU PLASTIC PRODUCTSCO.,LTD. |
|---|---|
| Submitter's address : | LIN QING ROAD, LUANNAN COUNTY,TANGSHAN CITY, HEBEI PROVINCE, 063503,CHINA |
| Phone number : | (86) 315-4169201 |
| Fax number : | (86)315-4169311 |
| Name of contact person: | Mr. Zhang Liang |
| Date the summary was prepared: | Dec. 30nd, 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, Colored(Yellow) |
|---|---|
| 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 (Yellow) 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 (Yellow) 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 (Yellow) 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 | Passes |
| Not a Primary Skin Irritation | ||
| Biocompatability | Dermal sensitization in the guinea pig | Passes |
| Not a Dermal sensitization |
[(b)(1)] A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Powder free vinyl patient examination gloves , Colored (Yellow) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. , it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses.
[{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 . It is as safe,as effective, and performed as well the legally marketed device identified in (a)(3).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tangshan Zhongpu Plastic Product 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 P.R. CHINA
MAR - 5 2010
Re: K100058
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 30, 2009 Received: January 8, 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.
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.
1f 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/Reporta Problem/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.
Susan Punney
Cathie D. Waters, R.S., M.S.
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 ZHONGPU PLASTIC PRODUCTS CO.,LTD.
510(k) Number (if known): *
Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)
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)
Elizabeth F. Llanes Will
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number: 00058
§ 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.