(109 days)
Not Found
No
The device description and performance studies focus on the physical properties and material characteristics of a patient examination glove, with no mention of AI or ML.
No.
The device, an examination glove, is intended to prevent contamination, not to treat or diagnose a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical patient examination glove, not a software application. The description focuses on physical dimensions, material properties, and performance characteristics of a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hands. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on physical characteristics and performance as a barrier (thickness, tensile strength, pinhole results).
- Performance Studies: The performance studies focus on physical properties, biocompatibility, and meeting standards for examination gloves. There are no studies related to analyzing biological samples or providing diagnostic information.
- Classification: The device is classified by the FDA as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ. This classification is for general and plastic surgery devices, not IVDs.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Subject device: Powder Free Clear Vinyl Patient Examination Glove
Color: Clear
Overall Length: 230mm min
Width: 94mm min
Palm Thickness: 0.09 mm min
Fingertip Thickness: 0.086 mm min
Non clinical performance tests
Significant physical and performance characteristics of the device: glove production is 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.
Subject Powder Free Clear Vinyl Patient Examination Glove do not contain any USP powder per the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. 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.
Overall Length: 230mm min
Width: 94mm min
Palm Thickness: 0.09 mm min
Fingertip Thickness: 0.086 mm min
Tensile Strength (Mpa) Before aging 15Mpa min
After aging 13Mpa min
Ultimate Elongations Before aging 495% min
After aging 415% min
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purposes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical performance tests conducted for physical and performance characteristics, residual powder, pinhole, biocompatibility (primary skin irritation, dermal sensitization), tensile strength, and ultimate elongation. All tests met the requirements specified by relevant ASTM standards (ASTM-D-5250-06, ASTM D-6124-06, ASTM D5151-06).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Residual Powder:
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2017
Zibo Yue Fan Medical Products Co, Ltd. % Kevin Wang Official Correspondent Intco Medical Industries, Inc. 805 Barrington Avenue Ontario, California 91764
Re: K170735
Trade/Device Name: Powder-Free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: May 19, 2017 Received: May 26, 2017
Dear Kevin Wang:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
James P. Bertram -S
for
CDR Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170735
Device Name
Powder-free Clear Vinyl Patient Examination Gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Zibo Yue Fan Medical Products Co., Ltd. The logo features a blue circle with a white hand inside on the left. To the right of the logo is the company name in bold, black text. There is a black line underneath the company name.
No.108 Waniie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000
510(K) SUMMARY
K170735
Submitter / 510(k) Sponsor
Zibo Yue Fan Medical Products Co., Ltd. No.108 Wanjie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000
Contact Person
Kevin Wang Official Correspondent Phone: 909 980 1678 Email: kevinwang@intcous.com
Summary Preparation Date
June 20, 2017
Type of 510(k) Submission
Traditional
Trade Name/ Classification
Name of Device/Trade Name: Powder Free Clear Vinyl Patient Examination Glove Classification: Patient Examination Glove Product Code: LYZ Product Class: Class I Regulation #: 21 CFR 880.6250 Classification Panel: General Hospital
Predicate Device
Powder-free PVC Vinyl Exam Gloves, Hebei Grandeast Plastic Products Co., Ltd. K142703
Device Description
Subject device: Powder Free Clear Vinyl Patient Examination Glove Color: Clear Overall Length: 230mm min Width: 94mm min
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Image /page/4/Picture/0 description: The image shows the logo for Zibo Yue Fan Medical Products Co., Ltd. The logo includes a blue circle with a white hand inside. The text "Zibo Yue Fan Medical Products Co., Ltd." is written in bold, black letters.
No.108 Waniie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000
Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min
Non clinical performance tests
Significant physical and performance characteristics of the device: glove production is 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.
Subject Powder Free Clear Vinyl Patient Examination Glove do not contain any USP powder per the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. 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.
Overall Length: 230mm min Width: 94mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min Tensile Strength (Mpa) Before aging 15Mpa min After aging 13Mpa min Ultimate Elongations Before aging 495% min After aging 415% min
Indications for 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.
5
Image /page/5/Picture/0 description: The image shows the logo for Zibo Yue Fan Medical Products Co., Ltd. The logo features a blue circle with a white hand inside on the left. The company name is written in bold black letters to the right of the logo. There is a black line underneath the company name.
No.108 Wanjie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000
| Device
Characteristics | Proposed Device | Predict Device | Comparison
Conclusion |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Product Name | Powder Free Clear Vinyl
Patient Examination Glove | Powder free PVC Vinyl
Exam Gloves | |
| 510(k) Number | K170735 | K142703 | |
| Product Owner | Zibo Yue Fan Medical
Products Co., Ltd. | Hebei Grandeast Plastic
Products Co., Ltd. | |
| Product Code | LYZ | LYZ | Same |
| Intended Use | Disposable device intended
for medical purposes that is
worn on the examiner's
hand or finger to prevent
contamination between
patient and examiner | Disposable device intended
for medical purposes that is
worn on the examiner's
hand or finger to prevent
contamination between
patient and examiner | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Sizes | Small
Medium
Large
Extra-Large | Small
Medium
Large
Extra-Large | Same |
| Length on Large
Size | Average over 232.23mm | Average over 230mm | Similar |
| Width of Palm on
Large Size | Average 95mm | Average 95mm | Similar |
| Palm Thickness | Average 0.095 mm | Average 0.095 mm | Similar |
| Fingertip
Thickness | Average 0.09 mm | Average 0.09 mm | Similar |
| Residual Powder | According to ASTM
D6124-06 Standard Test
Method for Residual
Powder on Medical gloves
for the determination of
residual powder content.
Testing result indicates the
weight of all types of
residual or powder on
finished powder-free
gloves as