(49 days)
Xing Yu 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.
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 and ASTM D5151.
The provided document is a 510(k) Premarket Notification for a medical device (Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's clinical performance against detailed acceptance criteria in the context of, for example, an AI/ML diagnostic device.
Therefore, the specific information requested in your prompt regarding acceptance criteria and a study to prove the device meets them (especially points 2-9, which relate to diagnostic performance studies) is not applicable in the context of this document.
However, I can extract information related to the performance specifications used to demonstrate substantial equivalence of the gloves, which are akin to acceptance criteria based on established standards for medical examination gloves.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The device's performance is measured against ASTM standards and FDA regulations for examination gloves. The "acceptance criteria" here are the requirements of these standards. The "reported device performance" indicates whether the device met these criteria.
| Characteristics | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension (Length) | ASTM D6319-10 (reapproved 2015): $\geq$ 230mm | $\geq$ 232mm (for all sizes) |
| Dimension (Width) | ASTM D6319-10 (reapproved 2015): Small 70-90mm, Medium 85-105mm, Large 100-120mm, XLarge 110-130mm | Small 76-88mm, Medium 89-102mm, Large 108-119mm, XLarge 115-128mm |
| Thickness (Fingertip) | ASTM D6319-10 (reapproved 2015): $\geq$ 0.05mm | $\geq$ 0.08mm |
| Thickness (Palm) | ASTM D6319-10 (reapproved 2015): $\geq$ 0.05mm | $\geq$ 0.08mm |
| Physical Properties (Tensile Strength Before Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 14MPa | 18-25MPa |
| Physical Properties (Tensile Strength After Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 14MPa | 17-22MPa |
| Physical Properties (Elongation Rate Before Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 500% | 530-600% |
| Physical Properties (Elongation Rate After Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 400% | 460-580% |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D6319-10 (reapproved 2015) - Test method: ASTM D5151-06 (reapproved 2015) | Passed Standard Acceptance Criteria (Tested with acceptable results) |
| Powder Residual | ASTM D6319-10 (reapproved 2015) - Test method: D6124-06 (reaffirmation 2011): Meets 0.1mg/glove (equivalent to below 2mg of residual powder implied by predicate comparison) | Meets 0.1mg/glove (Results generated values below 2mg of residual powder) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10: Third Edition 2010-08-01 (Not a primary skin irritant) | Passes (Not a primary skin irritant) |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10: Third Edition 2010-08-01 (Not a skin sensitizer) | Passes (Not a skin sensitizer) |
Non-Applicable Information for this Document:
The following points are typically relevant for diagnostic devices, especially those incorporating AI/ML. This 510(k) for examination gloves does not contain this type of information.
- Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical properties and biocompatibility, not a test set of data for diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic classifications is not established for this device.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (gloves), not an algorithm.
- The type of ground truth used: Not applicable. The "ground truth" for gloves is adherence to material, physical, and biocompatibility standards.
- The sample size for the training set: Not applicable. There is no AI/ML training set for this device.
- How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2017
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 Cn
Re: K171616
Trade/Device Name: Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 18, 2017 Received: June 1, 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.
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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 (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.
Tara A. Ryan -S
for Lori Wiggins 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171616
Device Name
XingYu Powder Free Nitrile Patient Examination Gloves, Blue Color
Indications for Use (Describe)
Xing Yu 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
"The assigned 510(k) number is:
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 : | 2017-07-18 |
2.0 Name of the Device
| Proprietary/Trade name: | Xingyu Powder Free Nitrile PatientExamination Gloves, Blue Color |
|---|---|
| Common Name: | Exam gloves |
| Classification Name: | 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 ExaminationGlove, Blue Color |
|---|---|
| Company name: | Tangshan Zhonghong Pulin Plastic Co., Ltd. |
| 510(K) Number: | K120970 |
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.
4.3 Physical and performance characteristics such as design, materials and physical properties:
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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 and ASTM D5151.
5.0 Device Indication for use:
Xingyu 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.
6.0 Summary of the Technological Characteristics of the Device:
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue 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 | $\geq$ 230mm | |
| Width | Small 70-90 mm | |
| Medium 85-105mm | ||
| Large 100-120mmX large 110-130 mm | ||
| Thickness | Fingertip $\geq$ 0.05mm | |
| Palm $\geq$ 0.05mm | ||
| PhysicalProperties | ASTM standard D 6319-10(Reapproved 2015)Tensile strength(Before aging) $\geq$ 14MPaTensile strength(After aging)Elongated rate(Before aging) $\geq$ 500%Elongated rate(After aging) $>$ 400% | |
| Freedom frompinholes | 21 CFR 800.20 | |
| ASTM standard D 6319-10(Reapproved 2015).Test method in accordance with ASTM D5151-06(Reapproved 2015) | Passed Standard Acceptance Criteria | |
| Powder Residual | ASTM standard D 6319-10(Reapproved 2015)Test method in accordance with D6124-06(Reaffirmation 2011) | Meets 0.1mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits ISO 10993-10: Third Edition 2010-08-01 | PassesUnder the conditions of the study, the subject device is not a primary skin irritant |
| Dermal sensitization in the guinea pig ISO 10993-10: Third Edition 2010-08-01 | PassesUnder the conditions of the study, the subject device is not a skin sensitizer |
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, Blue Color made by Shandong
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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 &Description | Predicate Device | Subject Device | Result ofComparison |
|---|---|---|---|
| Company | Tangshan Zhonghong PulinPlastic Co., Ltd. | Shandong Xingyu GlovesCo.,Ltd | -- |
| 510(K) Number | K120970 | K171616 | |
| Product name | Powder Free Nitrile PatientExamination Glove, BlueColor | Xingyu Powder FreeNitrile PatientExamination Gloves, Blue | similar |
| Product Code | LZA | LZA | same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | same |
| Indications forUse | Powder Free Nitrile PatientExamination Glove, BlueColor is a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer. | Powder Free NitrilePatient ExaminationGloves, Blue Color is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontaminationbetween patient and examiner. | similar |
| DeviceDescription andSpecifications | Meets ASTM D6319-10 | Meets ASTMD6319-10(Reapproved2015) | similar |
| Dimensions--LengthILS-2AQL4.0 | Meets ASTMD6319-10≥230mm min | 232 mm min for all sizes | similar |
| Dimensions-- WidthIL S-2AQL4.0 | Meets ASTM D6319-10Small 70-90 mmMedium 85-105mmLarge 100-120mmX large 110-130 mm | Small 76-88 mmMedium 89-102 mmLarge 108-119mmX large 115-128 mm | similar |
9.0 Substantial Equivalence Comparison:
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| Dimensions--ThicknessIL S-2AQL4.0 | Meets ASTM D6319-10 | Thickness (mm) min. | similar | ||
|---|---|---|---|---|---|
| Finger 0.05mm min.Palm 0.05mm min. | Finger 0.08Palm 0.08 | ||||
| PhysicalPropertiesIL S-2AQL4.0 | Meets ASTM D D6319-10 | Aging | Before | After | similar |
| Before aging/after agingTensile Strength≥ 14MPa | Elongation(%) | 530-600 | 460-580 | ||
| Before agingElongation ≥500%After agingElongation ≥400% | TensileStrength(MPa) | 18-25 | 17-22 | ||
| 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 accordance withASTM D5151(Reapproved 2015) withacceptable 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 | ||
| Compareperformancedata supportingsubstantialequivalence | MeetsASTM D5151-06(Reapproved 2015)ASTM D6319-10ASTM D6124-06(Reaffirmation 2011) | MeetsASTM D5151-06(Reapproved 2015)ASTM D6319-10(Reapproved 2015)ASTM D6124-06(Reaffirmation 2011) | similar | ||
| Single PatientUse | Single Patient Use | Single Patient Use | same | ||
| Biocompatibility | Under the conditions ofthis study, the test articlewas a non- irritant or non-sensitizer. | Under the conditions ofthis study, the test articlewas a non- irritant ornon- sensitizer. | same | ||
| SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10: Third Edition2010.08.01 |
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| Labeling for the | -Powder Free | -Powder Free | same |
|---|---|---|---|
| legally | -Patient Examination Glove | -Patient Examination Glove | |
| marketed device | -Single Use Only | -Single Use Only | |
| to which | - Manufactured For: | - Manufactured For: | |
| substantial | - Lot | - Lot | |
| equivalence is | -Blue color | -Blue color | |
| claimed. | - Non sterile | - Non sterile | |
Conclusion: 10.0
Based on the nonclinical tests data, it can be concluded that the Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color is as safe, as effective, and performs as well as the predicate device, Powder Free Nitrile Patient Examination Glove, Blue Color by Tangshan Zhonghong Pulin Plastic Co., Ltd., K120970.
§ 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.