(34 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4
Here's a breakdown of the acceptance criteria and study information for the device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | 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 | <2mg/glove |
| Biocompatibility: | ||
| 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 size for specific tests, nor does it specify the country of origin or whether the data was retrospective or prospective for the non-clinical tests. It refers to compliance with ASTM and ISO standards, which typically involve specific sample sizes outlined within those standards for each test (e.g., a certain number of gloves for physical property testing or a certain number of animals for biocompatibility).
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a patient examination glove, and the acceptance criteria are based on technical performance standards and biocompatibility, not on expert interpretation of medical images or data requiring ground truth establishment by human experts.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective measurements against established technical standards, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device (patient examination glove), not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study and the concept of human readers improving with AI assistance are irrelevant.
6. Standalone (Algorithm Only) Performance
Not applicable. There is no algorithm involved in the performance of a patient examination glove.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on established industry standards and regulatory requirements:
- ASTM Standard D 5250-00e4: This standard defines the specifications for vinyl patient examination gloves, covering dimensions, physical properties (e.g., tensile strength, elongation), and powder residual limits.
- 21 CFR 800.20: This U.S. FDA regulation specifies the leakage test (freedom from pinholes) for medical gloves.
- ASTM D6124-01 / ISO10993-10: These standards relate to biocompatibility testing, specifically primary skin irritation and dermal sensitization.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it's not an AI/machine learning product. The manufacturing process of gloves is subject to quality control, and units are sampled for testing against standards as part of a batch release, but this is not a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The standards themselves (ASTM, 21 CFR, ISO) are independently established through scientific consensus and regulatory processes to define acceptable performance for medical gloves.
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Summary
MAY - 4 2006
"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
I(@)(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 : | Wei Fang Jiuzhou Gloves Co., Ltd |
|---|---|
| Submitter's address : | No. 11 Yangshan Industrial Road, Linqu Wei FangShandong, P.R.China |
| Phone number : | (86) 536-3477888 |
| Fax number : | (86) 536-3477778 |
| Name of contact person: | Ms. Liu Xiang Jun |
| Date the summary was prepared: | 23 Feb 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, white(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 , white(non-colored) that meets all of the requirements of ASTM standard D 5250-00°4.
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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove, white(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 |
| Biocompatability | and D6124-01 | <2mg/glove |
| 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 , white(non-colored) meet requirements por 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2006
Wei Fang Jiuzhou Gloves 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
Re: K060884
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, White (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 1, 2006 Received: March 31, 2006
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 sqearcies. You must comply with all the Act's requirements, including, but not limited to: registretion and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing rogistice 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chin 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
Enclosure
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INDICATIONS FOR USE
Applicant: Wei Fang Jiuzhou Gloves Co., Ltd
510(k) Number (if known): ±0608 Y
Device Name: Powder Free Vinyl Patient Examination Gloves, White(Non-colored)
Indications For Use:
1 - 02-2-2 - 1 - 1 - 1 - 1 - 1 -
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)
Shila A. Murdaugh 3/2/04
f Anesthesiology, General Hospital,
Control, Dental Devices
Number. K660 884
§ 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.