(187 days)
No
The device description and performance studies focus on the physical and biological properties of a disposable glove, with no mention of AI or ML.
No.
The device, vinyl examination gloves, is intended to prevent contamination between patient and examiner, not to treat or alleviate a disease or condition.
No
The device is described as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." Its function is to provide a barrier, not to diagnose a condition.
No
The device is described as disposable medical PVC gloves, which are a physical product, not software. The description focuses on material properties and physical standards.
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 hand or finger. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and materials of the glove, not on any reagents, instruments, or software used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly described as a disposable medical device intended for barrier protection during patient examination.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile.
The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.
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)
Non-clinical tests were conducted to verify that the proposed device will meet acceptance criteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards: ISO 10993-5:2009, ISO 10993-10:2010, ASTM D5151-19, ASTM D5250-06 (Reapproved 2015), and ASTM D6124-06 (Reapproved 2017).
Key results include:
- Dimension (Length, Width, Thickness) according to ASTM D5250-06 (Reapproved 2015)
- Length: 233-241mm
- Width: Small 81-89mm, Medium 92-99mm, Large 102-109mm, X large 112-119mm
- Thickness: Fingertip 0.09-0.11mm, Palm 0.10-0.11mm
- Physical Properties (Tensile strength, Elongation) according to ASTM D5250-06 (Reapproved 2015)
- Tensile strength (Before & After aging): 17-25 MPa
- Elongation: Before aging 560-610%, After aging 460-570%
- Freedom from pinholes: Pass (Waterleakage test: Inspection Level I, AQL2.5, Accept/Reject criteria of 10/11)
- Powder Residual: Mean: 0.1mg/pcs (Meets
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
December 20, 2021
Liao Ning Shangwei Medical Products Co., Ltd. % Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang,Chaoyang District Beijing, 100121 China
Re: K211865
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: October 18, 2021 Received: December 17, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211865
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
.............................................................................................................................................................................. "The assigned 510(k) number is: K211865
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Liao Ning Shangwei Medical Products
Co.,Ltd. | | | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Submitter's address : | No.210 Management Committee
Office,Economic Development
Zone,Diaobingshan City,Tieling City,Liaoning
Province,112700,P.R. China | | | | |
| Phone number : | 0086-024-76518888
0086-024-76518888 | | | | |
| Name of contact person: | Mr. Zhu Hongqing | | | | |
| Date of preparation : | 2021-10-18 | | | | |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) | |
|--------------------------|----------------------------------------------------------------------|--|
| Proprietary/ Trade name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) | |
| Common Name: | Exam gloves | |
| Classification Name: | Patient examination glove | |
| Device Classifications: | I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Panel: | General Hospital | |
| Product Code: | LYZ | |
3.0 Predicate device
| Device Name: | Powder Free Vinyl Patient Examination Gloves,
Clear (non-colored) |
|----------------|----------------------------------------------------------------------|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd |
| 510(K) Number: | K091663 |
4.0 Device Description:
The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile.
The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.
4
5.0 Indications for Use Statement:
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:
The Poly (vinyl chloride) glove made of Poly Vinyl Chloride (PVC) rubber. The PVC film is water tight under normal conditions of use and its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure, so PVC glove can form a barrier to prevent contamination between patient and examiner worn them on his hand or finger.
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 2015). |
| 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 2015). |
| 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 2015) ASTM D5151-19 |
| Powder Residual | ASTM standard D 5250-06 |
| (Reapproved 2015).and | |
| D6124-06(Reapproved 2017) Meets |