(62 days)
The Nitrile Glove Powder Free Black 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 black. The proposed device is non-sterile.
This document is a 510(k) summary for a Nitrile Glove Powder Free Black, classifying it as a Class I medical device. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K171422).
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria & Reported Device Performance:
The document presents a "Technological Characteristic Comparison Table" (Table 1), "Device Dimensions Comparison" (Table 2), "Performance Comparison" (Table 3), and "Safety Comparison" (Table 4) where the proposed device's performance is compared against the predicate device and relevant standards. This serves as the primary method to demonstrate that the proposed device meets the acceptance criteria (substantial equivalence to the predicate and compliance with recognized standards).
| Acceptance Criteria Type | Acceptance Criteria | Proposed Device Performance (K182528) | Predicate Device Performance (K171422) | Comparison/Outcome |
|---|---|---|---|---|
| General Characteristics | ||||
| Product Code | LZA | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Intended Use | To prevent contamination between patient and examiner. | Same as predicate (quoted directly) | Same as proposed (quoted directly) | Same |
| Powdered Status | Powdered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | Nitrile Glove Powder Free Black, Non-Sterile | Disposable Powder Free Nitrile Examination Glove, Non-Sterile | Same (description-wise) |
| Dimensions | According to the predicate device's specifications | |||
| Length, mm (all sizes) | 230 min | 230 min | 230 min | Same |
| Width, mm (XS, S, M, L, XL) | 75, 85, 95, 105, 115 ±5 | 75, 85, 95, 105, 115 ±5 | 75, 85, 95, 105, 115 ±5 | Same |
| Thickness, mm (Finger, Palm) | 0.05 min | 0.05 min | 0.05 min | Same |
| Physical Properties (Before Aging) | ||||
| Tensile Strength | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 500% min | 500% min | 500% min | Same |
| Physical Properties (After Aging) | ||||
| Tensile Strength | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 400% min | 400% min | 400% min | Same |
| Compliance with Standard | Comply with ASTM D6319 | Comply with ASTM D6319 | Comply with ASTM D6319 | Same |
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151, AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151, AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151, AQL=2.5 | Same |
| Powder Content | Meet the requirements of ASTM D6124 | 0.48 mg per glove | Meet the requirements of ASTM D6124 | Similar (Specific value versus general compliance statement for predicate; assumed to meet the same standard) |
| Material Safety | ||||
| Material | Nitrile | Nitrile | Nitrile | Same |
| Biocompatibility: Irritation (ISO 10993-10:2010) | Not an irritant | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Same |
| Biocompatibility: Sensitization (ISO 10993-10:2010) | Not a sensitizer | Under conditions of the study, not a sensitizer. | Under conditions of the study, not a sensitizer. | Same |
| Biocompatibility: Cytotoxicity (ISO 10993-5:2009) | No potential toxicity to L-929 cells | Under conditions of the study, did not show potential toxicity to L-929 cells. | N/A (indicated by '/') | Similar (predicate doesn't explicitly state cytotoxicity but proposed device meets standard) |
2. Sample Sizes and Data Provenance (for test set, if applicable):
The document states, "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, it does not specify the sample sizes used for these non-clinical tests (e.g., how many gloves were tested for Freedom from Holes, Tensile Strength, etc.).
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for the data, other than the submitting company being located in China. Given the nature of these tests (bench testing for physical and chemical properties), they would typically be prospective tests performed on samples of the manufactured device.
3. Number of Experts and Qualifications (for ground truth of test set):
This information is not applicable to this submission type. Ground truth in this context typically refers to clinical diagnosis or pathology readouts. For a Class I medical device like a glove, the "ground truth" is adherence to physical/chemical standards and biocompatibility tests, not expert clinical interpretation. The "experts" would be the personnel in the testing laboratories conducting the ASTM and ISO standard tests. Their qualifications are inherent in their ability to perform these accredited tests.
4. Adjudication Method (for test set):
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic accuracy, where multiple human readers interpret data, and a consensus mechanism is employed to establish ground truth or resolve discrepancies. For physical and biocompatibility testing of a medical glove, objective laboratory test results are obtained, and no such adjudication is necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not done and is not relevant for this type of device. MRMC studies are typically performed for diagnostic imaging devices to assess the impact of AI on reader performance.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study was not done and is not applicable. This is a physical product (a glove), not an algorithm or AI-powered device.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance is established through:
- Compliance with recognized international and national standards: ISO 10993-10, ISO 10993-5, ASTM D6124-06, ASTM D5151-06, and ASTM D6319-10. These standards define the acceptable performance characteristics for medical gloves.
- Comparison to a legally marketed predicate device (K171422): Demonstrating that the proposed device's characteristics (dimensions, physical properties, material, biocompatibility) are substantially equivalent to a device already cleared by the FDA.
8. Sample Size for the Training Set:
This information is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
November 15, 2018
Haining Medical Products Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, 200120 Cn
Re: K182528
Trade/Device Name: Nitrile Glove Powder Free Black Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: September 7, 2018 Received: September 14, 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) K182528
Device Name Nitrile Glove Powder Free Black
Indications for Use (Describe)
The Nitrile Glove Powder Free Black 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 K182528
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Haining Medical Products Co.,Ltd. Address: West Of Dianchang Road,Luannan County, Tangshan City , Hebei Province , 063500 China Phone Number: +86-315-4167693 Contact: Zhiming Yao Date of Preparation: Nov.7, 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 Black Common name: Patient Examination Glove Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL
3.0 Classification
Production code: LZA Regulation number: 21 CFR 880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
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| Manufacturer: | Ever Global (Vietnam) Enterprise Corp |
|---|---|
| Device: | Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color |
| 510(k) number: | K171422 |
5.0 Indication for Use
The Nitrile Glove Powder Free Black 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 black. The proposed device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Proposed device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K182528 | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile GlovePowder FreeBlack is adisposable deviceintended formedical purposesthat is worn on theexaminer's handsto preventcontaminationbetween patientand examiner. | The DisposablePowder FreeNitrileExaminationGlove, White/Blue/ Black/ PinkColor is adisposabledevice intendedfor medicalpurposes that isworn on theexaminer'shands to preventcontaminationbetween patientand examiner. | Same |
| Powdered or | Powdered free | Powdered free | Same |
Table 1-General Comparison
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| Powered free | |||
|---|---|---|---|
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free Black, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Disposable Powder Free Nitrile Examination Glove, Non-Sterile | Same |
Table 2 Device Dimensions Comparison
| PredicateDevice(K171422) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| 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(K182528) | Designation | Size | Tolerance | ||||
| XS | S | M | L | XL | |||
| 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 | |||||
| Comparison | SAME |
Table 3 Performance Comparison
| Item | Proposed device (K182528) | Predicated device (K171422) | Comparison | ||
|---|---|---|---|---|---|
| Colorant | Black | White/ Blue/ Black/ Pink | Analysis 1 | ||
| Physical Properties | Before Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| Ultimate | 500% min | 500% min | Same |
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| ElongationTensileStrength | 14MPa, min | 14MPa, min | Same | ||
|---|---|---|---|---|---|
| AfterAging | UltimateElongation | 400% min | 400% min | Same | |
| Comply with ASTM D6319 | Comply with ASTM D6319 | Comply with ASTM D6319 | Same | ||
| Freedom from Holes | Be free fromholes whentested inaccordancewithASTMD5151AQL=2.5 | Be free fromholes whentested inaccordancewithASTMD5151AQL=2.5 | Same | ||
| Powder Content | 0.48 mg perglove | Meet therequirementsof ASTMD6124 | Similar |
Analysis 1: The proposed device has different color to the predicate device.
| Table 4 Safety Comparison | |
|---|---|
| --------------------------- | -- |
| Item | Proposeddevice(K182528) | Predicateddevice(K171422) | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO10993-10:2010BiologicalEvaluation ofMedicalDevices -Part 10:Tests ForIrritation AndSkinSensitization) | Under theconditions of thestudy, not anirritant | Under theconditions ofthe study, notan irritant | Same |
| Sensitization(ISO 10993-10:2010BiologicalEvaluation ofMedicalDevices - | Underconditions of thestudy, not asensitizer. | Underconditions ofthe study, nota sensitizer. |
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| Part 10:Tests ForIrritation AndSkinSensitization) | |||
|---|---|---|---|
| Cytotoxicity(ISO 10993-5:2009BiologicalEvaluation ofMedicalDevices -Part 5: TestsFor In VitroCytotoxicity) | Underconditions of thestudy, did notshow potentialtoxicity to L-929cells. | / | Similar |
8.0 Discussion of non-clinical and clinical test performed
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.
D6319-10(Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application.
Clinical testing is not needed for this device.
9.0 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.