(46 days)
The Nitrile Glove Powder Free White is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is white. The proposed device is non-sterile.
The provided document is a 510(k) summary for the "Nitrile Glove Powder Free White." This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a predicate device already on the market. It primarily focuses on comparing the new device's characteristics and performance to the predicate device and relevant standards, rather than describing a traditional clinical study with human subjects, AI involvement, or ground truth establishment as might be found for more complex diagnostic devices.
Therefore, many of the requested categories are not directly applicable or are not detailed in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by various ASTM and ISO standards, and the reported device performance indicates compliance with these standards.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Nitrile Glove Powder Free White) |
|---|---|
| Physical Properties (Before Aging): | |
| Tensile Strength (ASTM D6319) | 14MPa, min |
| Ultimate Elongation (ASTM D6319) | 500% min |
| Physical Properties (After Aging): | |
| Tensile Strength (ASTM D6319) | 14MPa, min |
| Ultimate Elongation (ASTM D6319) | 400% min |
| Compliance with ASTM D6319 | Complies |
| Freedom from Holes (ASTM D5151) | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 |
| Powder Content (ASTM D6124) | 0.47 mg per glove (meets requirements) |
| Biocompatibility: | |
| Irritation (ISO 10993-10) | Under the conditions of the study, not an irritant |
| Sensitization (ISO 10993-10) | Under conditions of the study, not a sensitizer. Complies with ISO10993-10 |
| Cytotoxicity (ISO 10993-5) | Under conditions of the study, device extract is not cytotoxic |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for tensile strength or holes). It refers to compliance with standards like ASTM D5151 and D6319, which would typically define such sample sizes. The data provenance is implied to be from laboratory testing performed by "Haining Medical Products Co., Ltd." or their designated testing facilities in China (as per the submitter's address). The tests are non-clinical tests, not studies with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and submission. The "ground truth" for medical gloves is established by objective physical and chemical testing against recognized international and national standards (e.g., ASTM, ISO) for properties like tensile strength, elongation, freedom from holes, powder content, and biocompatibility. There are no human "experts" establishing a "ground truth" in the clinical sense for this product's performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where subjective interpretation of images or other data by multiple readers is involved. For medical glove testing, objective measurements against pre-defined thresholds from standards are used.
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
This is not applicable. This document concerns a physical medical device (nitrile gloves), not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This document concerns a physical medical device (nitrile gloves), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by objective measurements and laboratory tests against the specific requirements and methodologies outlined in the referenced standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5). For example, "freedom from holes" is determined by a specific test method in ASTM D5151, not by expert consensus or pathology. Biocompatibility is assessed through standardized in-vitro and in-vivo tests as per ISO 10993.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned or relevant to this device's submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
December 21, 2018
Haining Medical Products Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, 200120 Cn
Re: K183068
Trade/Device Name: Nitrile Glove Powder Free White Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: October 29, 2018 Received: November 5, 2018
Dear Boyle Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Clarence W. Murray lii III -S
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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Indications for Use
510(k) Number (if known) K183068
Device Name Nitrile Glove Powder Free White
Indications for Use (Describe)
The Nitrile Glove Powder Free White is a disposable device intended purposes that is worn on the examiner's hands 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 K183068
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Haining Medical Products Co.,Ltd. Name: Address: West Of Dianchang Road,Luannan County, Tangshan City , Hebei Province , 063500 China Phone Number: +86-315-4167693 Contact: Zhiming Yao Date of Preparation: Dec.17.2018
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Nitrile Glove Powder Free White Common name: Patient Examination Gloves Regulation name: Non-powdered patient examination glove Model(s): XS, S. M. L. XL
3.0 Classification
Production code: LZA Requlation number: 21 CFR 880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/
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Blue/ Black/ Pink Color 510(k) number: K171422
5.0 Indication for Use
The Nitrile Glove Powder Free White is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device Description
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is white. The proposed device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Proposed Device(K183068) | Predicated Device(K171422) | Remark |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile GlovePowder Free whiteis a disposabledevice intendedfor medicalpurposes that isworn on theexaminer's handsto preventcontaminationbetween patientand examiner. | The DisposablePowder Free NitrileExamination Glove,White/ Blue/ Black/Pink Color is adisposable deviceintended formedical purposesthat is worn on theexaminer's handsto preventcontaminationbetween patientand examiner. | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-useindication, powderfree, device color,device name,glove size and | Single-useindication, powderfree, device color,device name, glovesize and quantity | Same |
Table1-General Comparison
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| quantity, NitrileGlove PowderFree White, Non-Sterile | Disposable PowderFree NitrileExamination Glove,Non-Sterile |
|---|---|
| ------------------------------------------------------------------ | ------------------------------------------------------------------------ |
Table2 Device Dimensions Comparison
| PredicateDevice(K171422) | Designation | Size | |||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | Tolerance | ||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Proposed Device(K183068) | Designation | Size | |||||
| XS | S | M | L | XL | Tolerance | ||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Same |
Table3 Performance Comparison
| Item | Proposed device(K183068) | Predicated device(K171422) | Remark | |
|---|---|---|---|---|
| Colorant | White | White/ Blue/Black/ Pink | Analysis1 | |
| PhysicalProperties | BeforeAging | Tensile Strength14MPa, min | 14MPa, min | Same |
| Ultimate Elongation500% min | 500% min | Same | ||
| AfterAging | Tensile Strength14MPa, min | 14MPa, min | Same | |
| Ultimate Elongation400%min | 400%min | Same | ||
| Comply with ASTM D6319 | Comply with ASTMD6319 | Same | ||
| Freedom from Holes | Be free from holes when tested in accordance | Be free from holes when tested in accordance | Same |
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| withASTMD5151AQL=2.5 | withASTMD5151AQL=2.5 | ||
|---|---|---|---|
| Powder Content | 0.47 mg per glove | Meet the requirements of ASTM D6124 | Similar |
Analysis1: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not effect on the safety of proposed device
| Item | Proposeddevice(K183068) | Predicateddevice(K171422) | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Under theconditions ofthe study, notan irritant | ||
| Sensitization(ISO 10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Underconditions ofthe study, nota sensitizer. | Comply withISO10993-10 | Same | |
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests ForIn VitroCytotoxicity) | Underconditions ofthe study,deviceextract is notcytotoxic | / | Similar |
Table4 Safety Comparison
8.0 Discussion of Non-clinical and Performance Testing
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Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.
9.0 Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated 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.