(36 days)
Powdered 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.
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
Here's an analysis of the provided text regarding the acceptance criteria and study for the ZIBO HENGDE PLASTIC&RUBBER PRODUCTS CO.,LTD Powdered Vinyl Patient Examination Gloves (K070008):
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 Amount | ASTM standard D 5250-00e4 | <10mg/dm2 (which meets the standard) |
| 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 provided document does not specify the sample size used for the test set for any of the performance measures.
The data provenance is also not explicitly stated. It's likely that the testing was conducted internally by ZIBO HENGDE PLASTIC&RUBBER PRODUCTS CO.,LTD or by a contracted laboratory, but the country of origin of the data is not mentioned. Given the company's location (China), it's probable the testing occurred there. This was a retrospective submission, as the notification was prepared and submitted for a device that had already undergone testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable/Not mentioned. This submission concerns a physical medical device (gloves) and its mechanical and biological properties. The "ground truth" here is objective measurement against established standards (ASTM, FDA regulations) and biological assays (rabbit irritation, guinea pig sensitization), rather than expert interpretation of complex data (like medical images) that would require a panel of experts.
4. Adjudication Method for the Test Set
Not applicable/Not mentioned. As noted above, the "ground truth" is based on objective measurements and established test protocols, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not relevant for this type of medical device (patient examination gloves). MRMC studies are typically used for diagnostic devices that involve human interpretation (e.g., radiologists reading medical images) to assess the impact of AI assistance on human performance. This submission focuses on the standalone performance of the physical glove.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence. The entire evaluation is based on the standalone performance of the device itself (the glove) against established objective standards and biological tests. There is no "algorithm" or "human-in-the-loop" component for this product. The device's performance characteristics (dimension, physical properties, pinhole freedom, powder amount, biocompatibility) were tested directly without human intervention or AI assistance.
7. The Type of Ground Truth Used
The ground truth used is a combination of:
- Established Industry Standards: Primarily ASTM standard D 5250-00e4.
- Regulatory Requirements: 21 CFR 800.20 (for pinholes).
- Pre-defined Biological Assay Outcomes: For biocompatibility (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs), where "Passes" or "Not a Primary Skin Irritation/Dermal sensitization" are the ground truth for an acceptable result.
- Other Standards: ASTM D6124-01 and ISO10993-10 are also referenced for meeting requirements (though not explicitly detailed in the table).
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device (gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of the gloves would involve quality control and process validation, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML training set, there is no ground truth established for it.
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Ko70008
Summary
8 2007 FEB
"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 : | ZIBO HENGDE PLASTIC&RUBBER PRODUCTS CO., LTD |
|---|---|
| Submitter's address : | Zhangdian District , SCIENCE/TEC. PARK OFZIBO , SHANGDONG PROVINCE, 255087, P. R. CHINA |
| Phone number : | (86)-533-3819127 |
| Fax number : | (86)-533-3818127 |
| Name of contact person: | Mr. NIE Jian |
| Date the summary was prepared: | Dec. 28,2006 |
((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: | Powdered Vinyl Patient Examination Gloves,Clear (Non-colored) | |
|---|---|---|
| Proprietary/Trade name: | Powdered 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 1* powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00t4
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.
{(a)(4)] A description of the device
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Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered 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 powdered vinyl patient examination gloves, Clear (non-colored) 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 Amount | ASTM standard D 5250-00e4 | <10mg/dm2 |
| 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 .
Powdered 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 Powdered Vinyl Patient Examination Gloves, Clear(non-colored) 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 the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
FEB
8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zibo Hengde Plastic & Rubber Products Company, Limited Mr. Chu Xiaoan Official Correspondent Room 1606 Building 1. Jianxiang Yuan, No 209 Bei Si Huan Zhong Road Beijing, China 10083
Re: K070008
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 28, 2006 Received: January 3, 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 deterrination does not Please be advised that TDA s issualled of a substance ice complies with other requirements mean that FDA nas made a decommances and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other to pacie of the Act of ally rederal statutes and regarents, including, but not limited to: registration You must comply with an the Fee 3 requirements in and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practic and lishing (21 CFR Part 807), laboring (21 CFR Part 820); and if f
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) This letter will anow you to begin finding of substantial equivalence of your device to a premiarket noniteation. The PDF midning of cassification 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), If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation in 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Super Runny
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
Enclosure
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INDICATIONS FOR USE
Applicant:_ZIBO HENGDE PLASTIC&RUBBER PRODUCTS CO.,LTD
510(k) Number (if known): *
Device Name: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)
Indications For Use:
Powdered 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 X (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)
Stela A Murphy to
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§ 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.