(79 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
The provided text is an FDA 510(k) summary for "Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device's performance against specific clinical efficacy or diagnostic accuracy criteria as would be required for a novel AI/imaging device.
Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, effect size, type of ground truth) are not applicable to this type of medical device submission. This submission relies on established performance standards for examination gloves.
Here's how the available information from the document applies to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document compares the subject device's performance against established ASTM standards and FDA requirements, as well as against the predicate device.
| Characteristics | Standard / Acceptance Criteria | Predicate Device Reported Performance (K091663) | Subject Device Reported Performance (K173017) | Result of Comparison |
|---|---|---|---|---|
| Dimension | ASTM D5250-06 (Reapproved 2011) | |||
| Length | ≥ 230mm | 231-241mm (Range) | 232-241mm (Range) | Same |
| Width (Small) | 80-90 mm | 81-89 mm (Range) | 82-88 mm (Range) | Same |
| Width (Medium) | 90-100mm | 93-99 mm (Range) | 93-98 mm (Range) | Same |
| Width (Large) | 100-110mm | 102-110 mm (Range) | 102-108 mm (Range) | Same |
| Width (X Large) | 110-120 mm | 111-119 mm (Range) | 113-118 mm (Range) | Same |
| Thickness (Fingertip) | ≥ 0.05mm | 0.05-0.10mm (Range) | 0.08-0.11mm (Range) | Same |
| Thickness (Palm) | ≥ 0.08mm | 0.09-0.13mm (Range) | 0.10-0.12mm (Range) | Same |
| Physical Properties | ASTM D5250-06 (Reapproved 2011) | |||
| Elongation (Before & After aging) | ≥ 300% | 340-410% (Range) | 350-420% (Range) | Same |
| Tensile Strength (Before & After aging) | ≥ 11MPa | 15-25 MPa (Range, specified as "> 14MPa" for predicate) | 15-20 MPa (Range) | Same |
| Freedom from Pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria; ASTM D5250-06; ASTM D5151-06 | Meets ASTM D5151-06 (Reapproved 2011), ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011), ASTM D5250-06 (Reapproved 2011) | Same (Holes at Inspection Level IAQL2.5) |
| Powder Residual | ASTM D5250-06 (Reapproved 2011), ASTM D6124-06 (Reaffirmation 2011) Meets < 2mg/glove | 0.3mg | 0.1mg | Same |
| Biocompatibility | ISO 10993-10: 2010-08-01 (Primary Skin Irritation in rabbits, Dermal sensitization in guinea pig) | Not an irritant/sensitizer (Meets ISO 10993-10:2002/Amd.1:2006) | Not an irritant/sensitizer (Meets ISO 10993-10 Third Edition 2010-08-01) | Same |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for pinholes, dimensions, etc.). However, it refers to "Inspection Level ILS-2 AQL 4.0" and "Inspection Level IAQL2.5" which are statistical sampling plans used in quality control (Acceptable Quality Levels). While these indicate a sampling methodology, the precise number of units sampled for each test is not explicitly stated.
- Data Provenance: The tests were performed on the subject device manufactured by Anhui Kindguard Medical Supplies Technology Co.,Ltd, located in China. The data would be derived from the manufacturing and quality control processes of the subject device. These are prospective tests performed on newly manufactured devices for the purpose of 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. For this type of device (patient examination gloves), "ground truth" is established through adherence to physical and chemical performance standards (e.g., ASTM standards for dimensions, tensile strength, freedom from pinholes, biocompatibility). These are objective measurements and laboratory tests, not subjective interpretations requiring multiple human experts.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods are typically relevant for subjective assessments (e.g., image interpretation where disagreements among readers need resolution). This submission relies on objective physical and chemical testing.
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 is not an AI or imaging device. It's a physical medical device (examination gloves). Clinical performance data (including MRMC studies) was explicitly stated as not needed to demonstrate substantial equivalence, and "determination of substantial equivalence is not based on an assessment of clinical performance data."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm based device.
7. The type of ground truth used:
- The "ground truth" here is defined by established consensus standards and regulatory requirements for patient examination gloves, specifically:
- ASTM D5250-06 (Reapproved 2011) - Standard Specification for Poly(vinyl chloride) Patient Examination Gloves
- ASTM D5151-06 (Reapproved 2011) - Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reaffirmation 2011) - Standard Test Method for Residual Powder on Medical Gloves
- 21 CFR 800.20 - Tests for leakage of medical devices
- ISO 10993-10: 2010-08-01 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- The device's performance is objectively measured against the specifications outlined in these standards.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or AI algorithm. The manufacturing process and quality control adhere to established standards, where the "training" analogous concept would be the development and adherence to manufacturing specifications and test methods.
9. How the ground truth for the training set was established:
- Not Applicable. As there's no training set, this question is not relevant. The "ground truth" for ensuring consistent product quality is embedded in the standardized manufacturing processes and quality control testing that align with the aforementioned ASTM and ISO standards.
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December 15, 2017
Anhui Kindguard Medical Supplies 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, 100121 CN
Re: K173017
Trade/Device Name: Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 16, 2017 Received: September 27, 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 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); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173017
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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510(K) Summary
"The assigned 510(k) number is: K173017 ..............................................................................................................................................................................
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name: | Anhui Kindguard Medical SuppliesTechnology Co.,Ltd |
|---|---|
| Submitter's address: | Intersection of Yulan Road and Chaoyang Road, Sixian County, Suzhou City,Anhui,234300, China |
| Phone number: | 0086-557-7606789 |
| Fax number: | 0086-557-7606789 |
| Name of contact person: | Chen Wei |
| Date of preparation: | 2017-09-16 |
2.0 Name of th e Device
| Device Name: | Powder Free Vinyl Patient ExaminationGloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Kindguard Powder Free Vinyl PatientExamination Gloves, Clear (non-colored) |
| CommonNam e | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Class ification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LYZ |
3.0 Predicate device
| Device Name: | Powder-Free Vinyl Patient Examination Glove(Non-colored) |
|---|---|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663. |
4.0 Device Description:
4.1 How the device functions:
PVC films form a barrier to prevent contamination between patient and examiner
4.2 Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
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4.3 Physical and performance characteristics such as design, materials and physical properties:
The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard |
|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011). |
| Length ≥230mm | |
| Width Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | |
| Thickness Fingertip ≥0.05mmPalm ≥0.08mm | |
| PhysicalProperties | ASTM D 5250-06(Reapproved 2011).Tensile strength (Before & After aging) ≥11MPaElongated rate (Before & After aging) ≥300% |
| Freedom frompinholes | 21 CFR 800.20 Passed Standard Acceptance CriteriaASTM D5250-06(Reapproved 2011)ASTM D5151-06(Reapproved 2011) |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011).and D6124-06(Reaffirmation 2011) Meets <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits PassesISO 10993-10: 2010-08-01 Under the conditionsof the study, thesubject device is not aprimary skin irritant. |
| Dermal sensitization in the guinea pig PassesISO 10993-10: 2010-08-01 Under the conditionsof the study, thesubject device is not askin sensitizer. | |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 (Reapproved 2011), per ASTM D6124-06 Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10:2010-08-01.
The performance test data of the nonclinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
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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. Determination of substantial equivalence is not based on an assessment of clinical performance data.
| Features & Description | Predicate Device | Subject Device | Result of Comparison | |||
|---|---|---|---|---|---|---|
| Company | Zhang Jia GangFengyuan PlasticProduct Co.Ltd. | Anhui KindguardMedical SuppliesTechnology Co.,Ltd | -- | |||
| 510(K) Number | K091663 | -- | ||||
| Product name | Powder Free VinylPatient ExaminationGloves, Clear(Non-colored) | Powder Free VinylPatient ExaminationGloves, Clear(non-colored) | Same | |||
| Product Code | LYZ | LYZ | Same | |||
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | Same | |||
| Intend for use | Powder free VinylPatient ExaminationGloves,Clear(Non-colored)is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontaminationbetween patient andexaminer. | Powder free VinylPatient ExaminationGloves, Clear(Non-colored) is adisposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger topreventcontaminationbetween patient andexaminer. | Same | |||
| Device Description andSpecifications | Meets ASTMD5250-06 | Meets ASTMD5250-06(Reapproved 2011) | Same | |||
| DimensionsLength(mm)ILS-2AQL4.0 | $\geq$ 230mm | 231-241mm | 232-241mm | Same | ||
| DimensionsWidth(mm)IL S-2AQL4.0 | Small | 80-90 | 81-89 | 82-88 | Same | |
| Medium | 90-100 | 93-99 | 93-98 | |||
| Large | 100-110 | 102-110 | 102-108 | |||
| X large | 110-120 | 111-1119 | 113-118 | |||
| DimensionsThickness(mm)IL S-2AQL4.0 | Finger | $\geq$ 0.05 | 0.05-0.10 | 0.08-0.11 | Same | |
| Palm | $\geq$ 0.08 | 0.09-0.13 | 0.10-0.12 | |||
| PhysicalPropertiesILS-2AQL4.0 | Before aging/after aging | Same | ||||
| Elongation | $\geq$ 300% | 340-410% | 350-420% | |||
| Tensile Strength> 14MPa | 15-25 MPa | 15-20 MPa |
9.0 Substantial Equivalence Comparison:
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| Holes atInspection LevelIAQL2.5 | Holes atInspection Level IAQL2.5 | Holes atInspection Level IAQL2.5 | Same | |
|---|---|---|---|---|
| Freedom fromPinholes | ||||
| ResidualPowder | below 2mg ofresidual powder | 0.3mg | 0.1mg | Same |
| Materials used to fabricatethe devices | PVC | PVC | Same | |
| Dusting or DonningPowder: name | Surface Coating Agent | Surface Coating Agent | Same | |
| Compare performance datasupporting substantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011) | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011) | Same | |
| Single Patient Use | Single Patient Use | Single Patient Use | Same | |
| Biocompatibility | Under the conditionsof this study, not anirritant and Under theconditions of thisstudy, not a sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Under the conditionsof this study, not anirritant and Under theconditions of thisstudy, not asensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10 ThirdEdition 2010-08-01 | Same | |
| Labeling for the legallymarketed device to whichsubstantial equivalence isclaimed. | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Same |
Substantial Equivalence Comparison: 10.0
Discussion: The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for water leak test on pinhole AQL., meeting labeling claims.
The subject device The Powder Free Vinyl Patient Examination Gloves, Clear (noncolored) has the same intended use and technological and performance characteristics as the predicate device Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Plastic Product Co., Ltd. K091663, and therefore the devices are substantially equivalent.
Conclusion: The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Plastic Product Co., Ltd. K091663.
§ 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.