(60 days)
Xingyu Powder Free Nittile Patient Examination Gloves, White 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 the patient and examiner
Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile 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 Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319-10(Reapproved 2015) and ASTM D5151-06(Reapproved 2015).
The document describes the conformity of the Xingyu Nitrile Powder Free Patient Examination Gloves, White color to established standards for patient examination gloves. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, many of the requested elements (multi-reader multi-case study, AI-related information, expert qualifications, adjudication methods) are not applicable.
Here's the information that can be extracted and formatted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance | Result of Comparison (to Predicate) |
|---|---|---|---|
| Dimension | ASTM D6319-10(Reapproved 2015) | Meets ASTM D6319-10 (Reapproved 2015) | Same |
| Length | ≥230mm | ≥230mm min for all sizes (Subject Device: 232mm min for all sizes) | Same |
| Width (Small) | 70-90 mm | 80-88 mm | Same |
| Width (Medium) | 85-105mm | 89-102 mm | Same |
| Width (Large) | 100-120mm | 104-118mm | Same |
| Width (X Large) | 110-130 mm | 115-129 mm | Same |
| Thickness (Fingertip) | ≥0.05mm | ≥0.08mm | Same |
| Thickness (Palm) | ≥0.05mm | ≥0.08mm | Same |
| Physical Properties | ASTM D6319-10(Reapproved 2015) | Meets ASTM D6319-10 (Reapproved 2015) | Same |
| Tensile strength (Before aging) | ≥14MPa | 18-25 MPa | Same |
| Tensile strength (After aging) | - (Assumed to be ≥14MPa based on predicate) | 17-21 MPa | Same |
| Elongated rate (Before aging) | ≥500% | 560-600% | Same |
| Elongated rate (After aging) | ≥400% | 460-560% | Same |
| Freedom from Pinholes | • 21 CFR 800.20• ASTM D6319-10(Reapproved 2015)• Test method in accordance with ASTM D5151-06(Reapproved 2015) | Passed Standard Acceptance CriteriaTested in accordance with ASTM D5151 (Reapproved 2015) with acceptable results | Same |
| Powder Residual | ASTM D6319-10(Reapproved 2015) Test method in accordance with D6124-06(Reaffirmation 2011) Meets 0.1mg/glove (summary), Below 2mg of residual powder (comparison table) | Meets 0.1mg/gloveResults generated values below 2mg of residual powder | Same |
| Biocompatibility | ISO 10993-10: Third Edition 2010-08-01 (Primary Skin Irritation in rabbits, Dermal sensitization in the guinea pig) | PassesNot a Primary Skin IrritationNot a Primary Skin IrritationUnder the conditions of this study, the test article was a non-irritant or non-sensitizer. (For both Skin Irritation and Dermal Sensitization Studies) | Same |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). It generally refers to "bench testing."
- Data Provenance: The tests were conducted by Shandong Xingyu Gloves Co., Ltd (China). The data implicitly comes from internal testing by the manufacturer. It is retrospective as it was completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study involving ground truth established by human experts. The "ground truth" for these tests are the established ASTM and ISO standards for glove performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no expert adjudication process for these types of physical and chemical tests. The results are based on objective measurements against defined standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document is for patient examination gloves, not an AI or imaging device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This document is for patient examination gloves, not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is objective measurement against pre-defined performance standards and regulatory requirements (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10, and 21 CFR 800.20 related to pinholes).
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device that requires a training set.
{0}------------------------------------------------
July 31, 2017
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shandong Xingyu Gloves 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, 100121, China
Re: K171615
Trade/Device Name: Xingyu Nitrile Powder Free Patient Examination Gloves, White color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: July 9, 2017 Received: July 19, 2017
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,
Mark S. Fellman -S
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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Xingyu Powder Free Nitrile Patient Examination Gloves, White Color
Indications for Use (Describe)
Xingyu Powder Free Nittile Patient Examination Gloves, White 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 the 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to 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 of information 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 regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) Summary
"The assigned 510(k) number is: K171615 "
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Shandong Xingyu Gloves Co.,Ltd |
|---|---|
| Submitter's address : | No.2158, Yaoqian Road,EconomicDevelopment Zone, GaomiCity,Shandong,261502,China |
| Phone number : | 0086-536-2588123 |
| Fax number : | 0086-536-2586328 |
| Name of contact person: | Xu Qiang |
| Date of preparation : | 2017-07-07 |
2.0 Name of the Device
| Device Name: | Powder Free Nitrile Patient ExaminationGloves,White Color |
|---|---|
| Proprietary/Trade name: | Xingyu Powder Free Nitrile PatientExamination Gloves,White Color |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |
3.0 Predicate device
| Device Name: | Powder Free Nitrile Patient ExaminationGloves, White Color |
|---|---|
| Company name: | JiangSu DongLing Plastic & Rubber Co., Ltd. |
| 510(K) Number: | K110248 |
4.0 Device Description:
4.1 How the device functions:
Nitrile films form a barrier to prevent contamination between patient and examiner.
4.2 Scientific concepts that form the basis for the device
The nitrile 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 Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319-10(Reapproved 2015) and ASTM D5151-06(Reapproved 2015).
5.0 Indication for use:
Xingyu Powder Free Nitrile Patient Examination Gloves, White 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.
6.0 Summary of the Technological Characteristics of the Device:
Xingyu Powder Free Nitrile Patient Examination Gloves,White Color, non-sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | |
|---|---|---|
| Dimension | ASTM standard D 6319-10(Reapproved 2015) | |
| Length | ≥230mm | |
| Width | Small 70-90 mm | |
| Medium 85-105mm | ||
| Large 100-120mm | ||
| X large 110-130 mm | ||
| Thickness | Fingertip ≥0.05mm | |
| Palm ≥0.05mm | ||
| PhysicalProperties | ASTM standard D 6319-10(Reapproved 2015) | |
| Tensile strength(Before aging) | ≥14MPa | |
| Tensile strength(After aging) | ||
| Elongated rate(Before aging) ≥500%Elongated rate(After aging) ≥400% | ||
| Freedom frompinholes | • 21 CFR 800.20• ASTM standard D6319-10(Reapproved 2015).Test method in accordance withASTM D5151-06(Reapproved 2015) | Passed StandardAcceptance Criteria |
| Powder Residual | ASTM standard D6319-10(Reapproved 2015)Test method in accordance withD6124-06(Reaffirmation 2011) | Meets0.1mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes |
| ISO 10993-10: Third Edition2010-08-01 | Not a Primary SkinIrritation | |
| Dermal sensitization in the guineapig ISO 10993-10: Third Edition2010-08-01 | PassesNot a Primary SkinIrritation |
7.1 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Powder Free Nitrile Patient Examination Gloves,White Color made by Shandong
{5}------------------------------------------------
Xingyu Gloves Co.,Ltd met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- . Dimension per ASTM D6319-10(Reapproved 2015),
- . Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ After aging) per ASTM D6319-10(Reapproved 2015),
- . Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20,
- . Powder Residual tests per ASTM D6319-10(Reapproved 2015)
- Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not needed to demonstrate that the subject glove is substantially equivalent to the predicate glove. So determination of substantial equivalence is not based on an assessment of clinical performance data.
| Features& | Predicate Device | Subject Device | Resultof | ||
|---|---|---|---|---|---|
| Description | Comparison | ||||
| Company | JiangSu DongLing Plastic | Shandong Xingyu Gloves | -- | ||
| & Rubber Co., Ltd. | Co.,Ltd | ||||
| 510(K) Number | K110248 | K171615 | |||
| Product name | Powder Free Nitrile Patient | Powder Free Nitrile | Same | ||
| Examination Gloves, White | Patient Examination | ||||
| Color | Gloves, White Color | ||||
| Product Code | LZA | LZA | Same | ||
| Size | Small/ Medium/ | Small/ Medium/ | Same | ||
| Large/X large | Large/X large | ||||
| Intended use | Powder Free Nitrile Patient | Powder | FreeNitrile | Same | |
| Examination Gloves, White | Patient | Examination | |||
| Color is a disposable device | Gloves,White Color is a | ||||
| intended for medical | devicedisposable | ||||
| purposes that is worn on the | intended | for medical | |||
| examiner's hand or finger to | purposes that is worn on | ||||
| prevent contamination | the examiner's hand or | ||||
| between patient and | fingerpreventto | ||||
| examiner. | contaminationbetween | ||||
| patient and examiner. | |||||
| Device | Meets ASTM D6319-10 | Meets ASTM | Same | ||
| Description and | D6319-10(Reapproved | ||||
| Specifications | 2015) | ||||
| Dimensions | Meets ASTM | 232 mm min for all sizes | Same | ||
| --Length | D6319-10 | ||||
| ILS-2 | ≥230mm min | ||||
| AQL4.0 | |||||
| Dimensions | Meets ASTM D6319-10 | Same | |||
| -- Width | Small | 70-90 mm | Small | 80-88 mm | |
| ILS-2 | Medium | 85-105mm | Medium | 89-102 mm | |
| AQL4.0 | Large | 100-120mm | Large | 104-118mm | |
| X large | 110-130 mm | X large | 115-129 mm | ||
| Dimensions--Thickness | Meets ASTM D6319-10 | Same | |||
| IL S-2AQL4.0 | Finger 0.05mm min.Palm 0.05mm min. | Thickness (mm) min.Finger 0.08Palm 0.08 | |||
| PhysicalProperties | Meets ASTM D D6319-10 | Aging | Before | After | Same |
| IL S-2AQL4.0 | Before aging/after agingTensile Strength≥ 14MPa | Elongation(%) | 560-600 | 460-560 | |
| Before agingElongation ≥500%After agingElongation ≥400% | 18-25 | 17-21 | |||
| TensileStrength(MPa) | |||||
| Freedom fromPinholes | Meets• 21 CFR 800.20• ASTM D6319-10 | Meets• 21 CFR 800.20• ASTM D6319-10(Reapproved2015) | Same | ||
| InspectionLevel I AQL2.5 | Test method in accordancewith ASTM D5151-06(Reapproved 2015) | Tested in accordancewith ASTM D5151(Reapproved 2015)with acceptable results | |||
| ResidualPowder | Meets ASTMD 6124-06(Reaffirmation 2011) | Meets ASTMD 6124-06(Reaffirmation 2011) | Same | ||
| below 2mg of residualpowder | Results generated valuesbelow 2mg of residualpowder | ||||
| Materials usedto fabricate thedevices | Nitrile | Nitrile | Same | ||
| Dusting orDonningPowder: name | Surface Coating Agent | Surface Coating Agent | Same | ||
| Standards | MeetsASTM D5151-06(Reapproved 2015)ASTM D6319-10ASTM D6124-06(Reaffirmation 2011) | MeetsASTM D5151-06(Reapproved 2015)ASTM D6319-10ASTM D6124-06(Reaffirmation 2011) | Same | ||
| Single PatientUse | Single Patient Use | Single Patient Use | Same |
9.0 Substantial Equivalence Comparison:
{6}------------------------------------------------
{7}------------------------------------------------
| Biocompatibility | Under the conditions of this study, the test articlewas a non- irritant or non-sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Under the conditions of this study, the testarticle was a non-irritant or non-sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10: Third Edition2010-08-01. | Same |
|---|---|---|---|
| Labeling | -Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-White color-Non sterile | -Powder Free-PatientExamination Glove-Single Use Only- Manufactured For:- Lot-White color-Non sterile | Same |
10.0 Conclusion:
Based on the nonclinical tests data, it can be concluded that the Xingyu Powder Free Nitrile Patient Examination Gloves,White Color is as safe, as effective, and performs as well as the predicate device, Powder Free Nitrile Patient Examination Gloves, White Color, JiangSu DongLing Plastic & Rubber Co., Ltd., K110248.
§ 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.