(130 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination and is not described as treating or alleviating a disease or condition.
No
Explanation: The device is described as a patient examination glove, intended to prevent contamination between patient and examiner. Its function is not to diagnose any condition but rather to provide a physical barrier.
No
The device is a physical medical device (patient examination gloves) and the summary describes physical characteristics and performance testing related to the material and construction of the gloves, not software.
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 a patient and an examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description reinforces the physical barrier function of the glove.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on physical properties (dimensions, tensile strength, elongation, pinholes) and biocompatibility (skin irritation, sensitization), which are relevant to a barrier device, not a diagnostic one.
- Classification: The device is classified as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ. This classification falls under "General and Plastic Surgery Devices," not IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This glove 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 on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
The proposed devices, Powder-free Vinyl Exam Gloves are non-sterile, clear, noncolored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Examiner's hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non Clinical Performance Tests:
- Scientific concepts: The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, to prevent contamination between patient and examiner; Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
- 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 Clear Vinyl Powder-free Patient Examination Gloves 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 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
- 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2017
Shandong Zhi Hong Medical Products, Co. Ltd. % Melo Zhang Official Correspondent Intco Medical Industries, INC. 805 Barrington Ave Ontario, California 91764
Re: K171317
Trade/Device Name: Clear Vinyl Powder-free Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: August 21, 2017 Received: August 23, 2017
Dear Melo Zhang:
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
1
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 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 (DICE) 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 (DICE) 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, Tara A. Ryan -S 2017.09.11 19:39:48 -04'00' for Lori 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) K171737
Device Name
Clear Vinyl Powder-free Patient Examination Gloves
Indications for Use (Describe)
A 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies onlyto requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regardingthis burden estimate or any other as pect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conductor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
3
Shandong Zhi Hong Medical Products, Co. Ltd.
231 Dongqi Industrial Park Qingzhou City, Shandong China
510(K) SUMMARY
Submitter / 510(k) Sponsor
Shandong Zhi Hong Medical Products, Co. Ltd. 231 Dongqi Industrial Park Qingzhou City, Shandong China
Contact Person
Melo Zhang Official Correspondent Phone: 909 980 1678 Email: melozhang@intcous.com
Summary Preparation Date
Sept 5, 2017
Type of 510(k) Submission
Traditional
Device Name / Classification
Name of Device: Clear Vinyl Powder-free Patient Examination Gloves Proprietary Name: Powder-Free Vinyl Patient Examination Gloves Common Name: Vinyl Patient Examination Glove Classification Name: 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
4
Image /page/4/Picture/0 description: The image contains the logo and name of a company. The logo is on the left side of the image and appears to be a stylized graphic. To the right of the logo is the text "Shandong Zhi Hong Medical Products, Co. Ltd." The text is in a bold, serif font, and the company name is underlined.
231 Dongqi Industrial Park Qingzhou City, Shandong China
Device Description
The proposed devices, Powder-free Vinyl Exam Gloves are non-sterile, clear, noncolored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Non Clinical Performance Tests
Scientific concepts: The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, to prevent contamination between patient and examiner; Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
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 Clear Vinyl Powder-free Patient Examination Gloves 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, 80L YZ, 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 (21CFR 880.6250)
5
Shandong Zhi Hong Medical Products, Co. Ltd.
231 Donggi Industrial Park Qingzhou City, Shandong China
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| Device
Characteristics | Proposed Device | Predict Device
(K142703) | Comparison
Conclusion |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Product Name | Shandong Zhi Hong Medical
Products, Co. Ltd.
Clear Vinyl Powder-free
Patient Examination Gloves, | Hebei Grandeast Plastic
Products Co., Ltd.
Glide-On Vinyl
Examination Gloves | |
| Product Code | LYZ | LYZ | Similar |
| 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 | Similar |
| 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