(16 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 5250-000
The provided document describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" and not an AI/ML device. Therefore, many of the requested categories for AI/ML device evaluation are not applicable.
Here's the information that can be extracted from the provided text regarding the glove's acceptance criteria and how its compliance was demonstrated:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00cd | Meets |
| Physical Properties | ASTM standard D 5250-00cd | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00cd & D6124-01 | < 2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes |
| Dermal sensitization in the guinea pig | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the testing of these gloves. The testing is based on compliance with ASTM standards, 21 CFR regulations, and ISO standards, which typically involve standardized methods for sampling and testing. No specific data provenance (country of origin, retrospective/prospective) is mentioned beyond the standards themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a medical glove, not an AI/ML diagnostic or assistive device. Ground truth is established by standardized physical and chemical testing methods, not expert interpretation.
4. Adjudication method for the test set
This is not applicable for a medical glove. The compliance is determined by laboratory testing against established physical, chemical, and biological standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a medical glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical glove.
7. The type of ground truth used
The "ground truth" for the medical glove is established by adherence to:
- Performance Standards: ASTM standard D 5250-00cd for Dimensions, Physical Properties, and Powder Residual.
- Regulatory Standards: 21 CFR 800.20 for Freedom from pinholes.
- Biocompatibility Standards: ASTM D6124-01 (for powder residual), ISO10993-10 for biocompatibility evaluation (Primary Skin Irritation and Dermal sensitization).
These standards define the objective criteria that the glove must meet.
8. The sample size for the training set
This is not applicable as the device is a medical glove. There is no "training set" in the context of an AI/ML device. The manufacturing process is designed to consistently produce gloves that meet the specified standards.
9. How the ground truth for the training set was established
This is not applicable as the device is a medical glove.
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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: 107 0000 (applicant leave blank) | ||||
|---|---|---|---|---|
| ------------------------------------------------------------------ | -- | -- | -- | -- |
JAN 19 2007
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: | 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, Shijjazhuang 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 5250-000
[(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 5250-00cd | Meets |
| Physical Properties | ASTM standard D 5250-00cd | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00cd | Meets |
| Biocompatability | and D6124-01 | <2mg/glove |
| 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 monclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder free vigyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5280-00th, 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.
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[(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/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered on the image and is the only element present.
od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Mr. Chu Xiaoan Zibo Hengde Plastic & Rubber Products Company, Limited Room 1606 Building 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Beijing, China 10083
JAN 1 9 2007
Re: K070006
Trade/Device Name: Powder Free 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 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 (OS) 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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): * K070006
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)
Shule H. My. Aug 18
ology, General Hosp
on Control, Dental Devices
K 070006
§ 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.