(88 days)
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 DS250-06.
The provided text describes a 510(k) submission for "Zibo Yingbo Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free". This document is for a medical device that is a glove, not an AI-powered diagnostic device. Therefore, the questions related to AI-powered diagnostics (such as ground truth, expert adjudication, MRMC studies, training/test sets, etc.) are not applicable in this context.
Here's an analysis based on the information provided, focusing on the quality and performance of the gloves:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D-5250-06 (Physical and Dimensions) | Meets all requirements |
| FDA 1000 ml Water Fill Test (Pinhole integrity) | Meets requirements (AQL 2.5, Inspection Level I) |
| Primary Skin Irritation Test | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) Test | No sensitization reactions |
| Powder Content | No more than 2 mg powder per glove (meets "powder-free" claim) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions "Inspection Level S-2, AOL 2.5" for Physical and Dimensional Testing and "AOL 2.5, Inspection Level I" for the FDA 1000 ml Water Fill Test. These refer to Acceptance Quality Limit (AQL) standards, which define the maximum percentage of defective units acceptable in a lot. They imply a sampling plan rather than a fixed sample size. The exact number of gloves tested for each lot is not explicitly stated but is determined by the AQL standard and lot size.
- Data Provenance: Not explicitly stated as country of origin for data, but the company is based in Zibo, Shandong, China. The testing was conducted to ASTM and FDA standards. The nature of the tests (physical, chemical, biocompatibility) means the "data provenance" is typically the lab where the tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI diagnostic device that requires expert-established ground truth. The "ground truth" for gloves is adherence to physical, chemical, and biological performance standards.
4. Adjudication method for the test set
- Not applicable. This is not an AI diagnostic device. Performance is determined by standardized test results against predefined criteria, not by human adjudication of diagnostic outputs.
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 is not an AI diagnostic device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- The "ground truth" for the gloves' performance is based on standardized laboratory test results that demonstrate compliance with established industry standards (ASTM D-5250-06) and regulatory requirements (FDA 1000 ml Water Fill Test, biocompatibility tests).
8. The sample size for the training set
- Not applicable. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI algorithm, so there is no training set or associated ground truth.
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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:
ﻌﺮﺳﻌ
..
NOV 2 2 2010 Zibo Yingbo Medical Products Co., Ltd. Oilu Chemical Industry Park Zhangdian District, Zibo, Shandong, China
Contact Person:
Mr. Yin, Guoliang, Product Manager Phone number: 011-86-13561658831
Date summary prepared: October 25, 2010
2. Name of the Device:
Zibo Yingbo Medical 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 DS250-06.
ડ. Intended 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)
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Comparison to Predicate Devices: 6.
Zibo Yingbo Medical 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.
Discussion of Non-Clinical tests performed for Determination of 7. Substantial Equivalence are as follows:
The standards used for Zibo Yingbo Medical 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 "powder-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 Yingbo Medical 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zibo Yingbo Medical Products, Incorporated C/O Mr. Frank Liu President Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
NOV 2 2 2010
Re: K102444
Trade/Device Name: Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Non Colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 25, 2010 Received: October 26, 2010
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: CDIRH, not evaluate information related to contract liability warranties. We remind you, Novever, 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/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.goy/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.
fams S.S.R
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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Zibo Yingbo Medical Products Co., Ltd.
Qilu Chemical Industry Park Zhangdian District, Zibo, Shandong, China
NOV 2 2 2010
INDICATIONS FOR USE
Applicant: Zibo Yingbo Medical Products Co., Ltd.
510(k) Number:
Device Name: Synthetic Vinyl Patient Examination Gloves - Powder Free
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 S.C. Laurie-Williams
Division of Anesthesiology, General Hospital intection Control, Dental Devices
510(k) Number: K102444
§ 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.