(16 days)
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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) are disposable devices which made of PVC material, intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the device, organized according to your requested information:
Description of Acceptance Criteria and Proving Study
This submission describes the acceptance criteria and performance for "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)". The device's performance is demonstrated through nonclinical testing against established ASTM standards and FDA regulations, as clinical data is explicitly stated as not being needed for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 and D6124-06 | Meets (<10mg/dm²) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10) | Passes, Not a Primary Skin Irritation |
| Dermal sensitization in the guinea pig (ISO 10993-10) | Passes, Not a Dermal sensitization |
The subsequent points (2-9) are not applicable to this device submission, as it concerns a Class I medical device (patient examination gloves) that relies on nonclinical testing against established standards rather than clinical studies with human participants, expert ground truth, or AI algorithms.
However, I will address each point and explain why it's not applicable in this context.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The "test set" here refers to physical gloves undergoing nonclinical laboratory tests according to standards like ASTM. While a sample size would have been used for tests like pinhole detection or physical properties, the document does not specify these individual sample sizes. The data provenance is from laboratory testing performed to meet specified standards.
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)
Not applicable. Ground truth, in the context of expert consensus, is not relevant for this device. The "ground truth" for glove performance is defined by the objective metrics and thresholds established within the referenced ASTM standards and FDA regulations (e.g., specific tensile strength values, acceptable pinhole rates, bio-reactivity tests).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies. This is not pertinent to the nonclinical testing of gloves against predefined physical and chemical 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
Not applicable. This device is a physical medical glove and does not involve AI, human readers, or image interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical glove and does not involve any algorithm or AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this device is based on established industry standards and regulatory requirements.
- For physical properties and dimensions: ASTM standard D 5250-06 e1 dictates the acceptable ranges and performance.
- For freedom from pinholes: 21 CFR 800.20 sets the standard.
- For powder residual: ASTM standard D 5250-06 e1 and D6124-06 set the acceptable limit.
- For biocompatibility: ISO 10993-10 outlines the testing methodology and acceptable outcomes (e.g., "Not a Primary Skin Irritation," "Not a Dermal Sensitization").
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning algorithm, the concept of establishing ground truth for it does not apply.
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Section C 510(k) Summary (21 CFR 807.92)
113195
NOV 1 6 2011
.
510(K) 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:
Premarket Notification [510(k)} Summary
| Submitter's name : | Suqian Ruijiang Medical Supplies Co., Ltd. |
|---|---|
| Submitter's address : | No.119 Hongzhehu Road, Suqian, Jiangsu, 223800, China |
| Phone number : | 86-527-84391929 |
| Fax number : | 86-527-84391929 |
| Name of contact person: | Mr.Donmei Yu |
| Date the summary was prepared | 2011-10-23 |
| Device Name: | Powdered Vinyl Patient Examination Gloves, Clear (non-colored) |
| Proprietary/Trade name: | Powdered Vinyl Patient Examination Gloves, Clear (non-colored) |
| Common Name: | Other clients private labelingExam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
Class I* Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM D 5250-06 e1.
Predicate device: Powdered Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091662.
Device Description: Powdered Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
Section C
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Device Intended Use(Indication for use): Powdered Vinyl Patient Examination Gloves, 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 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 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1and D6124-06 | Meets<10mg/dm² |
| Biocompatability | Primary Skin Irritation in rabbitsISO 10993-10Dermal sensitization in the guinea pigISO 10993-10 | PassesNot a Primary Skin IrritationPassesNot a Dermal sensitization |
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 D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and ISO 10993-10: 2002/Amd.1:2006.
The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
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.
The conclusions
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.
It can be concluded that the Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powdered Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091662.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sugian Ruijang Medical Supplies Company, Limited C/O Mr. Chu Xiaoan . Official Correspondent Beijing Easy-Link Company, Limited 1 Jian Xiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District, Beijing 100083 CHINA
NOV 1 6 2011
Re: K113195
Trade/Device Name: Powdered Vinyl Patient Examination Gloves. (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 23, 2011 Received: October 31, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Montour
Anthony D. Watson, B.S., M.S., M.B.A. 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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Section B Indications for Use
KI13195
INDICATIONS FOR USE
Suqian Ruijiang Medical Supplies Co., Ltd. Applicant: --1
510(k) Number (if known): *
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) Device Name:
Indications For Use: -- {
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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)
Eljchuth P. Caverne W
(Division Sign-Off)
Division of Anesthesiology General H
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number: _ K | | 3195
§ 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.