(49 days)
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow 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.
PVC films form a barrier to prevent contamination between patient and examiner. The PVC 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 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 document describes a 510(k) premarket notification for Kindguard Powder Free Vinyl Patient Examination Gloves. This is a Class I medical device, and the evaluation for substantial equivalence primarily relies on non-clinical performance data and comparison to a predicate device, rather than a study involving an AI algorithm or human readers.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets those criteria (especially those related to AI, human readers, ground truth establishment, sample sizes for training/test sets, and expert adjudication) are not applicable to this type of device and submission.
However, I can extract the relevant information regarding the acceptance criteria and the performance of this specific device based on the provided text.
Here's a breakdown of the requested information, with NA (Not Applicable) for elements not relevant to this submission type:
Acceptance Criteria and Device Performance for Kindguard Powder Free Vinyl Patient Examination Gloves
This submission is for a Class I medical device (patient examination gloves), which does not involve an AI algorithm or complex human interpretation tasks. Thus, the "study" proving acceptance is primarily a set of non-clinical performance tests and a comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard/Acceptance Criteria | Reported Device Performance (Kindguard Gloves) | Comparison Result |
|---|---|---|---|
| Form Factor / Dimensions | |||
| Length | ≥230mm (ASTM D 5250-06) | 231-241mm (Small, Medium, Large, X-Large) | Similar |
| Width (Small) | 80-90 mm (ASTM D 5250-06) | 81-89mm | Similar |
| Width (Medium) | 90-100 mm (ASTM D 5250-06) | 93-99mm | Similar |
| Width (Large) | 100-110 mm (ASTM D 5250-06) | 102-110mm | Similar |
| Width (X-Large) | 110-120 mm (ASTM D 5250-06) | 111-119mm | Similar |
| Thickness (Fingertip) | ≥0.05mm (ASTM D 5250-06) | 0.05-0.10mm | Similar |
| Thickness (Palm) | ≥0.08mm (ASTM D 5250-06) | 0.09-0.13mm | Similar |
| Physical Properties | |||
| Tensile Strength (Before & After aging) | ≥11MPa (ASTM D 5250-06) | 15-25 MPa (Before & After aging) | Same |
| Elongation Rate (Before & After aging) | ≥300% (ASTM D 5250-06) | 340-410% (Before & After aging) | Same |
| Freedom from Pinholes | Passed Standard Acceptance Criteria (21 CFR 800.20, ASTM D5250-06, ASTM D5151-06) | Holes at Inspection Level I, AQL2.5 | Passed / Same |
| Powder Residual | <2mg/glove (ASTM D 5250-06, D6124-06) | 0.3mg/glove | Meets |
| Biocompatibility | |||
| Primary Skin Irritation | Passes (ISO 10993-10: 2010-08-01 - "Not a primary skin irritant") | Passes (Under the conditions of the study, the device is not a primary skin irritant) | Passed |
| Dermal Sensitization | Passes (ISO 10993-10: 2010-08-01 - "Not a skin sensitizer") | Passes (Under the conditions of the study, the device is not a skin sensitizer) | Passed |
2. Sample size used for the test set and the data provenance:
- Sample Size for Testing: The specific number of gloves tested for each characteristic is not explicitly stated in this summary. However, tests were conducted according to the relevant ASTM and ISO standards, which define the required sample sizes for quality control and batch testing (e.g., AQL levels for pinholes).
- Data Provenance: The device manufacturer, Anhui Kindguard Medical Supplies Technology Co.,Ltd, is based in China. The testing would have been performed by or for the manufacturer. The data is based on prospective testing of the manufactured product to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- NA. For this type of device (patient examination gloves), "ground truth" is established through standardized physical, chemical, and biological tests (e.g., measuring tensile strength, water leak tests, biocompatibility assays) according to international standards (ASTM, ISO). There is no "expert consensus" on image interpretation or diagnostic performance in the traditional sense. The "experts" would be the qualified personnel performing these laboratory tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- NA. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments, particularly in medical imaging where multiple readers interpret cases. This is not applicable to the objective physical and chemical testing of medical gloves.
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:
- NA. This device does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- NA. This device does not use an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on objective, standardized measurements and laboratory test results performed according to specified ASTM and ISO standards (e.g., ASTM D5250 for dimensions and physical properties, ASTM D5151 for freedom from pinholes, D6124 for powder residual, ISO 10993-10 for biocompatibility). These standards define the acceptable range or pass/fail criteria.
8. The sample size for the training set:
- NA. This device does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established:
- NA. See point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 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: K173016
Trade/Device Name: Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 15, 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
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801); medical device reporting of medical device-related 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.
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 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,
Tara A. Ryan -S
for
Tina Kiang, PhD 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)
K173016
Device Name
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
Indications for Use (Describe)
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow 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.
| 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: K173016 "
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Anhui Kindguard Medical SuppliesTechnology Co.,Ltd | |||
|---|---|---|---|---|
| Submitter's address : | Intersection of Yulan Road andChaoyangRoad, 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 : | 2017-11-14 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient ExaminationGloves, Light Yellow Color |
|---|---|
| Proprietary/Trade name: | Kindguard Powder Free Vinyl PatientExamination Gloves, Light Yellow Color |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LYZ |
3.0 Predicate device
| Device Name: | Powder Free Vinyl Patient Examination Gloves,Light Yellow Color |
|---|---|
| Company name: | Jiangsu Healthcare Products Co., Ltd. |
| 510(K) Number: | K131831 |
4.0 Device Description:
- 4.1 How the device functions:
PVC films form a barrier to prevent contamination between patient and examiner Scientific concepts that form the basis for the device 4.2
The PVC 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 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, Light Yellow 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:
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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)Elongated rate (Before & After aging) | ≥11MPa≥300% | |
| Freedom frompinholes | • 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D5151-06(Reapproved 2011) | Passed StandardAcceptance Criteria | |
| Powder Residual | ASTM standard D 5250-06 (Reapproved2011).and D6124-06(Reaffirmation 2011) | Meets<2mg/glove | |
| Biocompatibility | Primary Skin Irritation in rabbitsISO 10993-10: 2010-08-01 | PassesUnder the conditionsof the study, the subjectdevice is not a primaryskin irritant. | |
| Dermal sensitization in the guinea pig ISO10993-10: 2010-08-01 | PassesUnder the conditionsof the study, the subjectdevice is not a skinsensitizer |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, 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.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not needed to demonstrate that the subject glove is substantially
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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 of Comparison | |
|---|---|---|---|---|
| Company | Jiangsu Healthcare Products Co., Ltd. | Anhui Kindguard Medical Supplies Technology Co.,Ltd | -- | |
| 510(K) Number | K131831 | K173016 | -- | |
| Product name | Powder Free Vinyl Patient Examination Gloves, Light Yellow Color | Powder Free Vinyl Patient Examination Gloves, Light Yellow Color | Same | |
| Product Code | LYZ | LYZ | Same | |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same | |
| Intend for use | Powder Free Vinyl Patient Examination Gloves, Light Yellow 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 Vinyl Patient Examination Gloves, Light Yellow 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 D5250-06 | Meets ASTM D5250-06(Reapproved 2011) | Same | |
| DimensionsLength (mm)ILS-2AQL4.0 | $\geq$ 230mm | 231-241mm | 232-243mm | Similar |
| DimensionsWidth (mm)IL S-2AQL4.0 | Small 80-90Medium 90-100Large 100-110X large 110-120 | 81-8993-99102-110111-119 | 83-8794-96103-107114-119 | Similar |
| DimensionsThickness (mm)IL S-2AQL4.0 | Finger $\geq$ 0.05Palm $\geq$ 0.08 | 0.05-0.100.09-0.13 | 0.08-0.110.10-0.11 | Similar |
| Physical PropertiesIL S-2AQL4.0 | Before aging/after aging | |||
| Elongation $\geq$ 300%Tensile Strength > 14MPa | 340-410%15-25 MPa | 350-410%15-20 MPa | Same | |
| FreedomfromPinholes | Holes atInspection LevelI AQL2.5 | Holes atInspection Level IAQL2.5 | Holes atInspection Level IAQL2.5 | |
| ResidualPowder | below 2mg ofresidual powder | 0.3mg | 0.1mg | Similar |
| 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 a sensitizer.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 |
9.0 Substantial Equivalence Comparison:
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10.0 Substantial Equivalence Comparison:
Discussion: The Powder Free Vinyl Patient Examination Gloves, Light Yellow Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meeting labeling claims.
The subject device Powder Free Vinyl Patient Examination Gloves, Light Yellow Color has the same intended use and technological and performance characteristics as the predicate device Powder Free Vinyl Patient Examination Gloves, Light Yellow Color Jiangsu Healthcare Products Co., Ltd. K131831.
Conclusion: Based on the nonclinical tests data, it can be concluded that the Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is as safe, as effective, and performs as well as the predicate device, Powder Free Vinyl Patient Examination Gloves, Light Yellow Color Jiangsu Healthcare Products Co., Ltd. K131831.
§ 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.