(74 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
The provided document is a 510(k) summary for Zibo Yuechuan Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It is intended for regulatory approval of a medical device, not an AI/ML powered device. Therefore, much of the requested information (like AI-specific metrics, expert ground truth, training sets, etc.) is not applicable here.
However, I can extract the relevant "acceptance criteria" (which in this context are performance standards for gloves) and how the device meets them based on the provided text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D5250-06 (Physical and Dimensions Testing) | Meets all requirements (Inspection Level S-2, AQL 2.5) |
| FDA 1000 ml Water Fill Test (Pinhole integrity) | Meets requirements (AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| Powder-Free Claim (powder content) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
| Biocompatibility requirements | Meets biocompatibility requirements (implied by skin irritation/sensitization tests) |
| Labeling Claims | Meets labeling claims |
| Applicable 21 CFR references | Conforms fully |
Study Details (as applicable for a non-AI medical device):
-
Sample size used for the test set and the data provenance:
- Pinhole Testing (FDA 1000 ml Water Fill Test): AQL (Acceptable Quality Limit) 2.5, Inspection Level I. The exact sample size is not explicitly stated but is determined by the AQL and inspection level standards, which refer to statistical sampling plans.
- Physical and Dimensions Testing: AQL 2.5, Inspection Level S-2. Similar to pinhole testing, the exact sample size is determined by the standard and specified AQL.
- Primary Skin Irritation and Skin Sensitization Testing: The document states "conducted with results showing no primary skin irritant or sensitization reactions," but does not specify the sample size of subjects or the methodology of these biological tests beyond the positive outcome.
- Data Provenance: Not specified, but generally, such tests are conducted in certified laboratories. The manufacturing origin is China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For this type of medical device (gloves), "ground truth" is established by adherence to physical, chemical, and biological performance standards, not by expert interpretation of data.
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Adjudication method for the test set:
- Not applicable. Performance is measured against quantitative and qualitative standards, not through adjudication of expert opinions.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is a study type for diagnostic algorithms or imaging, not for patient examination gloves.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
-
The type of ground truth used:
- Performance against established engineering and biological standards (e.g., ASTM D5250-06 for physical properties, FDA 1000ml water fill for barrier integrity, and standard biocompatibility tests for skin reactions).
-
The sample size for the training set:
- Not applicable, as this is not an AI/ML device. The "training" for such a product would be the manufacturing process control and quality system.
-
How the ground truth for the training set was established:
- Not applicable. The manufacturing process and quality checks ensure the product meets the specifications, guided by the aforementioned standards.
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APR 1 9 2011
510 (K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
1, Submitter's Identification:
Zibo Yuechuan Plastic Products Co., Ltd. 32 Yuming Road, Zhangdian District Zibo, Shandong, China
Contact Person: Cao, Yanan, General Manager Phone Number: 011-86-5333819566
Date summary prepared: February 1, 2011
2. Name of the Device:
Zibo Yuechuan Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free
3. Predicate Device Informaton:
Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
ડ. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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6. Comparison to Predicate Devices:
Zibo Yuechuan Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. and Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves. Powder free.
7. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Zibo Yuechuan Plastic Products Co., Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "bowder-free" claims (contain no more than 2 mg powder per glove).
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Zibo Yuechuan Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free conform fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1-9 2011
Zibo Yuechuan Plastic Products, Company, Limited C/O Mr. Frank Liu President Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
Re: K110338
Trade/Device Name: Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Non Colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 2, 2011 Received: February 4, 2011
Dear Mr. Liu:
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. Liu
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/ucm 115809.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. 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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Image /page/4/Picture/0 description: The image shows the logo of Zibo Yuechuan Plastic Products Co., Ltd. The logo includes a symbol that looks like a caduceus, which is a symbol of medicine. The text "Zibo Yuechuan Plastic Products Co., Ltd." is written in a bold, sans-serif font and is underlined. The logo is simple and professional, and it clearly identifies the company.
32 Yuming Road, Zhangdian District Zibo, Shandong, China
INDICATIONS FOR USE
Zibo Yuechuan Plastic Products Co., Ltd. Applicant:
510(k) Number:
Device Name:
Patient Vinyl Examination Gloves, Powder free, Non-Sterile, Non Colored
Indications of Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over the Counter Use _____X
Factory Initials
Elizabeth F. Clawie-William
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110338
§ 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.