(132 days)
Not Found
No
The device is a simple barrier glove and the summary contains no mention of AI, ML, or related concepts.
No.
The device acts as a barrier to prevent contamination, which is a diagnostic or protective function, not a therapeutic one.
No
Explanation: The device is described as a "Powder Free Vinyl Patient Examination Gloves" intended to "prevent contamination between patient and examiner." It acts as a barrier and there is no mention of it being used to identify or analyze diseases or conditions.
No
The device is a physical glove made of Poly (vinyl chloride) and is described as a disposable device worn on the hand or finger. It is 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 clearly stated as a barrier worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (Poly (vinyl chloride)) and its function as a barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies mentioned are related to the physical properties and safety of the glove as a barrier (ASTM standards, biocompatibility), not the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
DAIYANG Powder Free 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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
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)
The device was tested against the following standards:
- ASTM D 5250-06(Reapproved 2011) for Dimension and Physical Properties
- 21 CFR 800.20 and ASTM D5151-06(Reapproved 2011) for Freedom from pinholes
- ASTM standard D 5250-06 (Reapproved 2011) and D6124-06(Reaffirmation 2011) for Powder Residual
- ISO 10993-10: 2010-08-01 for Biocompatibility (Primary Skin Irritation in rabbits and Dermal sensitization in the guinea pig)
Key Results:
- Dimensions (Length, Width, Thickness) meet or are similar to the predicate device and ASTM standards.
- Physical Properties (Tensile strength, Elongated rate) meet or are similar to the predicate device and ASTM standards.
- Freedom from pinholes meets acceptance criteria.
- Powder Residual meets the standard of
§ 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 a stylized symbol of three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Zibo Daiyang Plastic Company % Chu Xiaoan Official Correspondent Beijing Easylink Co., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Beijing, CN 100121
Re: K162259
Trade/Device Name: DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 8, 2016 Received: November 22, 2016
Dear Chu 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.
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
1
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 (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 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162259
Device Name
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
DAIYANG Powder Free 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.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
The assigned 510(k) number is:______K162259
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Zibo Daiyang Plastic Company |
|---|---|
| Submitter's address : | North of Shiji Rd,Zhuangyuan Industrial Park, |
| Zhangdian,Zibo,Shandong,255087,China | |
| Phone number : | 0086-533-3813666 |
| Fax number : | 0086-533-3811696 |
| Name of contact person: | Yang Yan Hong |
| Date of preparation : | 2016-12-16 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) |
|-------------------------|------------------------------------------------------------------------------|
| Proprietary/Trade name: | DAIYANG Powder Free Vinyl Patient
Examination Gloves, Clear (non-colored) |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LYZ |
3.0 Predicate device
| Device Name: | Powder-Free Vinyl Patient Examination Glove
(Non-colored) |
|----------------|--------------------------------------------------------------|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663. |
4.0 Device Description:
4.1 How the device functions:
PVC films form a barrier to prevent contamination between patient and examiner
4.2 Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
4
4.3 Physical and performance characteristics such as design, materials and physical properties:
The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
5.0 Device Intended Use (Indication for use):
DAIYANG Powder Free 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.
6.0 Summary of the Technological Characteristics of the Device:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard |
|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011). |
| Length ≥230mm | |
| Width | |
| Small 80-90 mm | |
| Medium 90-100mm | |
| Large 100-110mm | |
| X large 110-120 mm | |
| Thickness Fingertip ≥0.05mm | |
| Palm ≥0.08mm | |
| Physical | |
| Properties | ASTM D 5250-06(Reapproved 2011). |
| Tensile strength (Before & After aging) ≥11MPa | |
| Elongated rate (Before & After aging) ≥300% | |
| Freedom from | |
| pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria |
| ASTM D5250-06(Reapproved 2011) | |
| ASTM D5151-06(Reapproved 2011) | |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011).and D6124-06(Reaffirmation 2011) Meets |