(181 days)
Powder Free Nitrile Patient Examination Gloves, Black 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 body fluids and bloodborne Pathogens. 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. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
The provided document is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Black Color". It details the device's characteristics and compares it to a predicate device to establish substantial equivalence.
Here's the information about the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6319-10 (e.g., Length ≥230mm min for all sizes) | Meets (e.g., Length 230mm min for all sizes, Width values are provided and specific) |
| Physical Properties | ASTM standard D 6319-10 (e.g., Elongation ≥500%, Tensile Strength ≥14MPa) | Meets (e.g., Elongation: 520-620%, Tensile Strength: 20-36 MPa) |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D 5151-06 (Reapproved 2011) (Inspection Level I, AQL 2.5) | Meets (Holes at Inspection Level I, AQL 2.5) |
| Powder Residual | ASTM standard D 6319-10 and D6124-06 (Reapproved 2011) (< 2mg/glove) | Meets (< 2mg/glove; Results generated values below 2mg of residual powder) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10: Third Edition 2010-08-01) | Passes (non-irritant) |
| Biocompatibility | Dermal sensitization in the guinea pig (ISO 10993-10: Third Edition 2010-08-01) | Passes (non-sensitizer) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for each test. It refers to compliance with ASTM standards, which would implicitly define sample sizes for those tests.
The data provenance is from China as the submitter, Suqian Xingye Glove Co, Ltd, is located in Suqian City, Jiangsu Province, China. The studies are retrospective, as they involve testing of a manufactured device according to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for these types of devices is objective measurement against specified standards, rather than expert interpretation. For biocompatibility, it's typically conducted by trained laboratory personnel following standard protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods such as 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessment. This document describes objective performance testing against established ASTM and ISO standards for physical properties, barrier integrity, and chemical content. Therefore, no adjudication method as described would be applicable or necessary. The standard itself defines the pass/fail criteria.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, especially with AI assistance. The device in question is a patient examination glove, and its effectiveness is determined by its physical and chemical properties, not by human reader performance or AI collaboration.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the device. The device is a physical medical glove, not an algorithm or software. Its performance is evaluated through physical and chemical laboratory testing as described by the standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the test set is established by objective, quantitative standards and specified test procedures defined by:
- ASTM standard D 6319-10 (for Dimension and Physical Properties)
- 21 CFR 800.20 and ASTM D 5151-06 (Reapproved 2011) (for Freedom from Pinholes)
- ASTM standard D 6319-10 and D6124-06 (Reapproved 2011) (for Powder Residual)
- ISO 10993-10: Third Edition 2010-08-01 (for Biocompatibility – Primary Skin Irritation and Dermal Sensitization)
These standards specify the methodology and acceptance limits for each characteristic.
8. The sample size for the training set
This information is not applicable. The device is a medical glove, not an AI or machine learning model that requires a training set. The manufacturing process for gloves is subject to quality control and process validation, not a "training set" in the context of data-driven systems.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Suqian Xingye Glove 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: K152271
Trade/Device Name: Nitrile Powder Free Patient Examination Gloves, Black Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 03, 2016 Received: January 11, 2016
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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Page 2 - Chu Xiaoan
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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Division 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) K152271
Device Name
Powder Free Nitrile Patient Examination Gloves, Black Color
Indications for Use (Describe)
Powder Free Nitrile Patient Examination Gloves, Black 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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Section 6 510(k) Summary
510(K) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: K152271 =
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Suqian Xingye Glove Co,Ltd |
|---|---|
| Submitter's address : | Dongwu Road,Economic DevelopmentZone,Suqian City,JiangsuProvince,223800,China |
| Phone number : | 0086-527-82860533 |
| Fax number : | 0086-527-82860080 |
| Name of contact person: | Jian Zhong Deng |
| Date of preparation : | 2016-01-03 |
Name of the Device 2.0
| Device Name: | Powder Free Nitrile Patient ExaminationGloves, Black Color |
|---|---|
| Proprietary/Trade name: | Powder Free Nitrile Patient ExaminationGloves, Black 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: | Black Nitrile Powder Free Exam Glove |
|---|---|
| Company name: | Shandong Yuanhang Medical Products Co., Ltd. |
| 510(K) Number: | K133307 |
4.0 Device Description:
How the device functions: 4.1 Nitrile films form a barrier to body fluids and bloodborne Pathogens
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Scientific concepts that form the basis for the device 4.2
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.
Physical and performance characteristics such as design, materials and 4.3 physical properties:
Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
5.0 Device Intended Use (Indication for use):
Powder Free Nitrile Patient Examination Gloves, Black 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:
The Powder Free Nitrile Patient Examination Gloves, Black Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 6319-10. | Meets |
| Physical Properties | ASTM standard D 6319-10. | Meets |
| Freedom from pinholes | 21 CFR 800.20 ASTM D 5151-06 (Reapproved 2011) | Meets |
| Powder Residual | ASTM standard D 6319-10 and D6124-06(Reapproved 2011). | Meets<2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbitsISO 10993-10: Third Edition2010-08-01. | PassesUnder the conditions ofthis study, the test article wasa non-irritant |
| Dermal sensitization in theguinea pigISO 10993-10: Third Edition2010-08-01. | PassesUnder the conditions ofthis study, the test article wasa non-sensitizer |
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7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
Powder Free Nitrile Patient Examination Gloves, Black Color, meet requirements per ASTM D6319-10.per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: Third Edition 2010-08-01.
The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data is not needed for the subject device.
9.0 Substantial Equivalence Comparison:
| Features &Description | Predicate Device | Subject Device | Result ofComparison |
|---|---|---|---|
| Company | Shandong YuanhangMedical Products Co.,Ltd. | Suqian Xingye GloveCo,Ltd | -- |
| 510(K) Number | K133307 | ||
| Product name | Black Nitrile PowderFree Exam Glove | Powder Free NitrilePatient ExaminationGloves, Black Color | same |
| Product Code | LZA | LZA | same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | same |
| Indications foruse | A disposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner. | Powder Free NitrilePatient ExaminationGloves, Black Color is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner. | Substantiallyequivalent |
| DeviceDescription andSpecifications | Meets ASTMD6319-10 | Meets ASTMD6319-10 | Substantiallyequivalent |
| Dimensions--Length | Meets ASTMD6319-10$≥230$ mm min | 230mm min for all sizes | Substantiallyequivalent |
| Dimensions-- Width | Meets ASTMD6319-10 | Substantiallyequivalent | |
| Small 70-90 mmMedium 85-105mmLarge 100-120mmXlarge 110-130 mm | Small 82-86 mmMedium 94-98mmLarge 105-109mmX large 114-120 mm | ||
| Dimensions | Meets ASTM | Substantially | |
| --Thickness | D6319-10 | Thickness (mm) min. | equivalent |
| Finger 0.05mm min. | Finger 0.10-0.12 | ||
| Palm 0.05mm min. | Palm0.06-0.09 | ||
| Physical | Meets ASTM D | Substantially | |
| Properties | D6319-10 | equivalent | |
| Before aging/after aging | Before aging/after aging | ||
| Elongation ≥500% | Elongation :520-620% | ||
| Tensile Strength≥14MPa | Tensile Strength:20-36 MPa | ||
| Freedomfrom | Meets● | Meets ASTMD5151-06 | Substantiallyequivalent |
| Pinholes | 21 CFR 800.20ASTM D6319-10● | (Reapproved 2011) | |
| ASTM D 5151-06● | |||
| (Reapproved 2011) | Holes at | ||
| Inspection Level IAQL2.5 | |||
| Residual | Meets ASTM | Meets ASTM | Substantially |
| Powder | D 6124-06 | D 6124-06 | equivalent |
| (Reapproved 2011) | (Reapproved 2011) | ||
| below 2mg of residual | Results generated values | ||
| powder | below 2mg of residual | ||
| powder | |||
| Materials used | Nitrile | Nitrile | Substantially |
| to fabricate the | equivalent | ||
| devicesDusting or | PU | PU-120C | Substantially |
| Donning | equivalent | ||
| Powder: | |||
| Dusting or | Surface Coating Agent | Surface Coating Agent | Substantially |
| DonningPowder: name | equivalent | ||
| Compare | Meets | Meets | Substantially |
| performance | ASTM D5151-06 | ASTM D5151-06 | equivalent |
| data supporting | (Reapproved 2011) | (Reapproved 2011) | |
| substantialequivalence | ASTM D6319-10ASTM D6124-06 | ASTM D6319-10ASTM D6124-06 | |
| (Reapproved 2011) | (Reapproved 2011) | ||
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially |
| equivalent | |||
| Biocompatibility | Under the conditions ofthis study, the test article | Under the conditions ofthis study, the test article | Substantially |
| was a non- irritant or non- | was a non- irritant or non- | equivalent | |
| sensitizer. | sensitizer. | ||
| SKIN IRRITATION | IRRITATIONSKIN | ||
| DERMAL and | DERMALand | ||
| SENSITIZATION | SENSITIZATION | ||
| STUDIES Meets ISO | STUDIES MeetsISO | ||
| 10993-10:2002/Amd.1:2006 | 10993-10: Third Edition2010-08-01. | ||
| Labeling for the | -Powder Free | -Powder Free | Substantially |
| legally marketed | -Patient Examination | -Patient Examination | equivalent |
| device to which | Glove | Glove | |
| substantial | -Single Use Only | -Single Use Only | |
| equivalence isclaimed. | - Manufactured For:- Lot | - Manufactured For:- Lot | |
| -Black color | -Black color | ||
| - Non sterile | - Non sterile |
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10.0 Substantial Equivalence Comparison:
It can be concluded that the Powder Free Nitrile Patient Examination Gloves, Black Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.
It can be concluded that the Powder Free Nitrile Patient Examination Gloves, Black Color is as safe, as effective, and performs as well as the predicate device, Black Nitrile Powder Free Exam Glove, Shandong Yuanhang Medical Products Co., Ltd. K133307.
The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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.