(265 days)
Not Found
No
The device is a physical glove and the summary does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
The device, Powder Free Nitrile Patient Examination Gloves, Blue Color, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment.
No
Explanation: The device is described as a glove worn on the examiner's hand to prevent contamination, which is a barrier function, not a diagnostic one. There is no mention of it being used to detect or identify a disease or condition.
No
The device is described as Powder Free Nitrile Patient Examination Gloves, which are physical gloves worn on the hand. The description and performance studies focus on material properties and physical integrity, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The description clearly states the device is a "Powder Free Nitrile Patient Examination Glove" intended to be "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device used on the body (the examiner's hand) and for physical protection, not for analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, reagents, or diagnostic information derived from testing specimens.
Therefore, based on the provided information, this device is a medical glove, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Nitrile Patient Examination Gloves, Blue Color 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
LZA
Device Description
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. 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
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
Non-clinical tests were conducted to verify that the proposed device will meet acceptance crtiteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below: 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 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ASTM D5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.
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 crtiteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below: 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 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ASTM D5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.
Clinical testing is not needed for this device.
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
January 16, 2019
JiangSu DongXin Medical Technology Co., Ltd % Chu Xiaoan Official Correspondent Beijing Easylink Co., Ltd Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang Beijing, 100021 Cn
Re: K181106
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: November 27, 2018 Received: December 11, 2018
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/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,
Clarence W. Murray lii III -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181106
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Color
Indications for Use (Describe)
Powder Free Nitrile Patient Examination Gloves, Blue Color 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.
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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510(k) Summary
K181106
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92
1.0 Submitter:
| Submitter's name : | JiangSu DongXin Medical Technology Co.,Ltd |
|---|---|
| Submitter's address : | LongJin Road,The Economic Development Zone |
| of SuCheng,SuQian City,JiangSu Province, | |
| 223800 China. | |
| Name of contact person : | Deng Yujie |
| Date of preparation : | 2019-01-14 |
Designated Submission Correspondent
| Company's name | Beijing Easy-Link Company |
|---|---|
| Company 's address | Rm. F302 Bldg., 41, Jing Cheng Ya Ju, |
| Courtyard 6 of Southern Dou Ge Zhuang, | |
| Chaoyang District, Beijing 100121, P.R. China | |
| Contact person | Chu Xiaoan |
2.0 Name of the Device
| Proprietary/Trade name: | Powder Free Nitrile Patient Examination
Gloves, Blue Color |
|-------------------------|---------------------------------------------------------------|
| Common Name: | Patient Examination gloves |
| Classification Name: | Non-powdered Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |
3.0 Predicate device
| Device Name: | Powder Free Nitrile Patient Examination
Glove, Blue Color |
|----------------|--------------------------------------------------------------|
| Company name: | Tangshan Zhonghong Pulin Plastic Co., Ltd. |
| 510(K) Number: | K120970 |
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4.0 Device Description:
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
5.0 Indications for Use Statement:
Powder Free Nitrile Patient Examination Gloves, Blue Color 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.
Technological Characteristic Comparison Table: 6.0
| Features & Description | Predicate Device (K120970) | Subject Device (K181106) | Comparison |
|---|---|---|---|
| Product name | Powder Free Nitrile Patient Examination Glove, Blue Color | Powder Free Nitrile Patient Examination Gloves, Blue Color | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Product Code | LZA | LZA | same |
| Color | Blue | Blue | same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | same |
| Indications for Use | Powder Free Nitrile Patient Examination Glove, Blue Color 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. | Powder Free Nitrile Patient Examination Gloves, Blue Color 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. | same |
| Device Description and Specifications | Meets ASTM D6319-10 | Meets ASTM D6319-10 | same |
| Dimensions --Length | |||
| ILS-2 AQL4.0 | Meets ASTM D6319-10 | ||
| ≥230mm min | 232 mm min for all sizes | similar | |
| Dimensions -- Width | |||
| IL S-2 AQL4.0 | Meets ASTM D6319-10 | ||
| Small 70-90 mm | |||
| Medium 85-105mm | |||
| Large 100-120mm | |||
| X large 110-130 mm | Small 76-90 mm | ||
| Medium 89-102 mm | |||
| Large 108-119mm | |||
| X large 115-128 mm | similar | ||
| Dimensions --Thickness | |||
| IL S-2 AQL4.0 | Meets ASTM D6319-10 | ||
| Finger 0.05mm min. | |||
| Palm 0.05mm min. | Thickness (mm) min. | ||
| Finger 0.08 | |||
| Palm 0.08 | similar |
5
| Physical Properties
IL S-2
AQL4.0 | | Aging
Elongation
(%) | Before | After | similar |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|---------|
| | Meets ASTM D D6319-10 | | 550-600 | 450-570 | |
| | Before aging/after aging
Tensile Strength≥
14MPa | Tensile
Strength
(MPa) | 18-25 | 17-22 | |
| | Before aging
Elongation ≥500% | | | | |
| | After aging
Elongation ≥400% | | | | |
| Freedom from
Pinholes
Inspection Level I
AQL2.5 | Meets
• 21 CFR 800.20
• ASTM D6319-10 | 1) Inspection Level I AQL2.5,and Accept/Reject criteria of 10/11
2) Water leakage test: 5 noncompliance is allowed. | | | similar |
| Residual Powder | Meets ASTM
D 6124-06
(Reaffirmation 2011)
below 2mg of residual
powder | 1) Checked on 5pcs sub-samples (N=5).
2) Result as following:
Mean: 0.1mg/pcs | | | similar |
| Materials used to
fabricate the devices | Nitrile | Nitrile | | | same |
| Single Patient Use
Biocompatibility | Single Patient Use
Under the conditions
of this study, the test
article was a non-
irritant or non-
sensitizer | Single Patient Use
Under the conditions of
this study, the test
article was a non-
irritant or non-
sensitizer
Under the conditions of
this study, the test
article was non-
cytotoxicity to L-929
cells. | | | similar |
| Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed. | -Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot
-Blue color | -Powder Free
-Patient Examination
Glove
-Single Use Only - Manufactured For:
- Lot
-Blue color | | | same |
7.0 Discussion of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device will meet acceptance crtiteria for each test. The test results demonstrated that the proposed device met the
6
acceptance criteria found in the following standards below:
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 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ASTM D5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.
8.0 Discussion of Clinical and Performance Testing
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 legally marketed predicated device.