(41 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, yellow) that meets all of the requirements of ASTM standard D 5250-00t4.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Colored (White, Yellow)":
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from Pinhole | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00e4 and D6124-01 | Meets (<2mg/glove) |
| 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 the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for testing each characteristic (Dimension, Physical Properties, Freedom from Pinhole, Powder Residual, Biocompatibility).
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. The studies were conducted to meet "ASTM standard D 5250-00-4, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10," which are international and US standards. The testing itself would typically be prospective for these types of device characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to this type of device and study. The testing for examination gloves involves physical and chemical property measurements against established international and regulatory standards, not expert interpretation of qualitative data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation or subjective assessments, often in medical imaging or clinical trials, to resolve discrepancies. The tests for these gloves are objective measurements against defined 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 information is not applicable. MRMC studies are relevant for AI-assisted diagnostic devices or imaging systems. This document describes a medical device (examination gloves) that does not involve human "readers" or Artificial Intelligence.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical product (examination gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance characteristics of these gloves is defined by the specified ASTM and CFR standards. These standards provide objective measurement methodologies and acceptance limits for physical dimensions, tensile strength, elongation, freedom from pinholes, and powder residue. For biocompatibility, the ground truth is established by the results of animal testing (rabbits and guinea pigs) against established toxicological assessment criteria compliant with ISO10993-10.
8. The sample size for the training set
This information is not applicable. There is no "training set" for this type of medical device testing. Training sets are used in machine learning and AI development.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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C Summary
JUN 1 4 2005
"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
[(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 : | SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD |
|---|---|
| Submitter's address : | NO.78 CANGSHI ROAD, JINZHOU CITY, HEBEI, 052260, P.R.CHINA |
| Phone number : | (86)0311-4318269 |
| Fax number : | (86)0311-4322592 |
| Name of contact person: | Mr. Guo Huanqiang |
| Date the summary was prepared: | 4 April 2005 |
[(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(White, 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 (white, yellow) that meets all of the requirements of ASTM standard D 5250-0004.
Predicate device : Powder-Free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD K042119 .
[(a)(4)] A description of the device
Device Description : powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00t4.
Section C Page 1of 2
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K05 1156
{(a)(5)] The summary describes the intended use of the device
Device Intended Use: powder free vinyl patient examination glove colored (white, 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 5250-00e4 | 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 | 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 .
Powder free vinyl patient examination gloves (white, yellow) meet requirements per ASTM D5250-00-4, 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 logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
JUN 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shijiazhuang Manful Light Industrial Products Company C/O Mr. Chu Xiaoan TUV Rheinland Beijing Office Rm. 1606, Bldg. 1 Jianxiang Yuan No 209 Bie Si Huan ZhongRoad Haidian District, Beijing, CHINA 100083
Re: K051156
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (White, Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 4, 2005 Received: May 4, 2005
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Quettie y. Michael Davis.
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: SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD
510(k) Number (if known): K051156
Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (White,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)
Zada L. Mighlick 4/14/15
Anesthesiology, General Hospital Infection Control. D
510(k) Number: K151132
§ 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.