(61 days)
Not Found
No
The device description and testing focus on the physical properties and biocompatibility of a standard examination glove, with no mention of AI or ML capabilities.
No.
The device is described as a glove intended for preventing contamination, not for treating a disease or condition.
No
The device is described as "Vinyl Patient Examination Glove" and its intended use is to "prevent contamination between patient and examiner." This function is for protection and hygiene, not for diagnosing medical conditions.
No
The device is a physical examination glove, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiners hands to prevent contamination between patient and examiner." 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 standards related to the glove itself (material, powder content, strength, freedom from holes). It doesn't mention any components or functions related to analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostics.
- Testing: The performance studies and key metrics relate to the physical integrity and biocompatibility of the glove, not the accuracy or performance of a diagnostic test.
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 is a physical barrier used during examination.
N/A
Intended Use / Indications for Use
The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTMD5151, and ASTMD5250. The proposed device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
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 on the proposed subject device to demonstrate that the device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves
ASTMD5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
October 6, 2018
Jiangxi Zhonghong Pulin Medical Products Co., Ltd % Boyle Wang Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai. 200120 Cn
Re: K182117
Trade/Device Name: Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: July 20, 2018 Received: August 6, 2018
Dear Boyle 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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510(k) Summary K182117
This summary of 510(k) information is in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. Address: Yinsha Wan Industrial Park, High-tech Industrial Zone of Hukou County, Jiujiang City, Jiangxi Province Phone Number: +86-315-4168700 Contact: Joe Zhang Date of Preparation: 10/3/2018
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel:+86-18930777676, Fax:+86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Vinyl Patient Examination Gloves
Vinyl Patient Examination Gloves (Powder Free) Common name:
Regulation name: Non-Powdered Patient Examination Glove
Model(s): XS, S, M, L, XL 3.0 Classification
Production code: LYZ Regulation number: 21 CFR 880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Manufacturer: Hebei Hongtai Plastic Products Company Limited
4
Device: Vinyl Patient Examination Gloves (White, Blue, Yellow) 510(k) number: K163168
5.0 Intended use
The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
The intended use and the indication for use of Vinyl Patient Examination Glove, as described in its labeling are the same as the predicate device Vinyl Patient Examination Gloves (White, Blue, Yellow) (K163168).
6.0 Device description
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTMD5151, and ASTMD5250. The proposed device is non-sterile.
7.0 Technological Characteristics Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Proposed device | Predicated device | Remark |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | The Vinyl Patient | ||
| Examination Glove is a | |||
| disposable device | |||
| intended for medical | |||
| purposes that is worn on | |||
| the examiner ' s hands to | |||
| prevent contamination | |||
| between patient and | |||
| examiner. | The Vinyl Examination | ||
| Glove (White, Blue, or | |||
| Yellow) is a disposable | |||
| device intended for | |||
| medical purposes that | |||
| is worn on the | |||
| examiner's hands to | |||
| prevent contamination | |||
| between patient and | |||
| examiner. | Same | ||
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Surface Feature | Smooth | Smooth | Same |
| Labeling Information | Single-use indication | Single-use indication | Same |
Table1-General Comparison
5
| powder free, device color,
device name, glove size
and quantity, Vinyl
Examination Gloves,
Non-Sterile | powder free, device
color, device name,
glove size and quantity,
Vinyl Examination
Gloves, Non-Sterile |
| -------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------- |
|---|
Table2 Device Dimensions Comparison
| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K163168) | XS | S | M | L | XL | ||
| Length, mm | 230 | 230 | 235 | 245 | 245 | min | |
| Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Proposed Device | Designation | Size | Tolerance | ||||
| XS | S | M | XS | S | |||
| Length, mm | 230 | 230 | 235 | 245 | 245 | min | |
| Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | SAME |
Table3 Performance Comparison
| Item | Proposed device | Predicated device | Remark | ||
|---|---|---|---|---|---|
| Colorant | Clear, Non-Colored | White, Blue, Yellow | Analysis1 | ||
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile | ||||
| Strength | 15MPa, min | 15MPa, min | SAME | ||
| Ultimate | |||||
| Elongation | 380%min | 380%min | SAME | ||
| After | |||||
| Aging | Tensile | ||||
| Strength | 15MPa, min | 15MPa, min | SAME | ||
| Ultimate | |||||
| Elongation | 380%min | 380%min | SAME | ||
| Comply with ASTM D5250 | Comply with ASTM D5250 | Comply with ASTM D5250 | SAME | ||
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=1.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=1.5 | SAME | ||
| Powder Content | 0.48 | Meet the requirements of ASTM D6124 | SIMILAR |
Analysis1: The proposed device has a different color in comparison to the predicate device. The difference in color of the subject device did not raise a safety concern because biocompatibility test results were passing for the subject device.
6
| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Material | Vinyl | Vinyl | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under conditions of the study, not cytotoxic | / | SIMILAR | |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Table4 Safety Comparison
8.0 Discussion of non-clinical and clinical test performed
Non-clinical tests were conducted on the proposed subject device to demonstrate that the device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves
ASTMD5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
Clinical testing is not needed for this device.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicated device.