(23 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 5250-00ed.
Here's an analysis of the provided text regarding the acceptance criteria and study that proves the device meets those criteria:
Device: Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00e4. | Meets |
| Physical Properties | ASTM standard D 5250-00e4. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 and D6124-01 | Meets, <2mg/glove |
| Biocompatibility: | ISO10993-10 | |
| - Primary Skin Irritation | Primary Skin Irritation in rabbits (ISO10993-10) | Passes, Not a Primary Skin Irritation |
| - Dermal Sensitization | 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 sample sizes used for the specific tests (e.g., freedom from pinholes, physical properties, biocompatibility). It only indicates that the device "Meets" the specified ASTM and CFR standards.
The data provenance is not explicitly mentioned as retrospective or prospective, nor are country of origin of the data. The tests are described as being performed to meet international and US standards (ASTM, 21 CFR, ISO), which implies general laboratory testing rather than data collected from specific patient populations or geographical regions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For device testing of physical and chemical properties and biocompatibility, the "ground truth" is typically defined by the established testing protocols and acceptance limits within the referenced standards (e.g., ASTM D 5250-00e4, 21 CFR 800.20, ISO10993-10) rather than requiring expert consensus on individual results in the same way clinical image interpretation might. The tests are designed to be objective and measurable.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method. For the type of objective physical and chemical testing performed for gloves, adjudication methods like 2+1 or 3+1 are typically not applicable. Results are against predefined criteria from standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging AI). This device is a medical glove, which is a physical barrier device, and its effectiveness is determined by its physical properties and biocompatibility, not by human interpretation or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable to the device. The device is a physical medical glove, not an algorithm or an AI-powered system. Therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is based on objective measurements and predefined criteria as established by recognized industry standards and regulations. Specifically:
- ASTM Standard D 5250-00e4: For Dimension, Physical Properties, and Powder Residual.
- 21 CFR 800.20: For Freedom from pinholes (which relates to the Acceptable Quality Level or AQL for water leak testing).
- ISO 10993-10: For Biocompatibility (Primary Skin Irritation and Dermal Sensitization).
These standards specify the methods of testing and the acceptance limits that define whether a glove "meets" the standard.
8. Sample Size for the Training Set
This information is not applicable and not provided. As a medical glove, the device does not employ machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.
9. How Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons mentioned under point 8.
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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 " (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 : | Tangshan hongyun Plastic Products co., ltd |
|---|---|
| Submitter's address : | South wangzhuang, Pachigang, Luannan Town, HebeiProvince, 063500, P. R. China |
| Phone number : | (86) - 315-4426258 |
| Fax number : | (86) - 315-4426258 |
| Name of contact person: | Mr. GENG Haitao |
| Date the summary was prepared: | Jul 10 2007 |
[(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 5250-0004.
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 5250-00ed.
[(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 5250-00e4. | Meets |
| Physical Properties | ASTM standard D 5250-00e4. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 | Meets |
| and D6124-01 | <2mg/glove | |
| Biocompatability | Primary Skin Irritation inrabbits | PassesNot a Primary Skin Irritation |
| Dermal sensitization in theguinea 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 D5250-006, 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 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2007
Mr. Chu Xiaoan Official Correspondent Tangshan Hongyun Plastic Products Company, Limited Room 1606 Building 1 Jianxiang Yuan, No.209 Bei Si Huan Zhong Road Beijing 10008 P.R. CHINA
Re: K072001
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: July 10, 2007 Received: July 23, 2007
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 such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Clars
Chris Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
Applicant: Tangshan hongyun Plastic Products 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)
ivision Sign-Off) ivision of Anesthesiology, General Hospital ifection Control, Dental Devices
*10(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.