(149 days)
The Nitrile Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
The provided text is a 510(k) Premarket Notification from the FDA for Nitrile Patient Examination Gloves. It details the device's characteristics and its comparison to a predicate device, focusing on physical properties, safety, and compliance with established standards.
The request asks for information regarding acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/ML-driven medical device, including aspects like sample sizes, expert involvement, ground truth, and MRMC studies.
However, the provided document DOES NOT describe an AI/ML-driven device. It describes a physical medical device: Nitrile Patient Examination Gloves. Therefore, much of the requested information (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance, AI assistance effect size) is not applicable to this document.
I will focus on the applicable aspects of the request based on the provided document.
Acceptance Criteria and Study for Nitrile Patient Examination Glove
The study described is a non-clinical performance and safety testing of the Nitrile Patient Examination Glove to demonstrate its substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a detailed table in Section 8.0, "Discussion of Non-clinical and Performance Testing," outlining the acceptance criteria and results.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: ≥220; M/L/XL: ≥230. Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10. Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length (mm): >230 (Pass) Width (mm): XS: 77-79, S: 81-84, M: 88-91, L: 103-107, XL: 111-115 (Pass) Thickness (mm): Finger: 0.08-0.09, Palm: 0.08-0.09 (Pass) |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.01 (mg/glove) (Pass) |
| ASTM D412 | Physical Properties - Before Aging | Tensile Strength: ≥14MPa Ultimate Elongation: ≥500% | Tensile Strength: 15.0-17.9 (Pass) Ultimate Elongation: 533-553 (Pass) |
| ASTM D412 | Physical Properties - After Aging | Tensile Strength: ≥14MPa Ultimate Elongation: ≥400% | Tensile Strength: 15.8-17.4 (Pass) Ultimate Elongation: 532-550 (Pass) |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. (Pass) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document explicitly states "0/125 leaks" for the Watertightness Test. This indicates a sample size of 125 units for that specific test. For other tests (e.g., physical dimensions, tensile strength, cytotoxicity, irritation, sensitization), the exact sample sizes are not explicitly stated in the provided text, but results are given in ranges or as definitive passes (e.g., "15.0-17.9" for tensile strength, suggesting multiple measurements).
- Data Provenance: The tests are described as "Non-clinical tests," implying they were conducted in a laboratory setting by the manufacturer, PingAn Medical Products Co.,Ltd. The company's address is listed in China ("Zheji road ,High-tech Industrial Zone of Hukou County, Jiujiang City, Jiangxi Province,332500 China"). The data is considered prospective as it's generated for the purpose of this premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized test methods (ASTM, ISO) and laboratory measurements, not by expert consensus or interpretations. There's no subjective human interpretation involved in determining if a glove has a hole or meets tensile strength requirements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This concept is not applicable. Adjudication methods are relevant for subjective assessments, typically in image interpretation or clinical diagnosis, where multiple readers might disagree. For physical and chemical property testing of a medical glove, objective measurements against established standards are performed.
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 concept is not applicable as the device is a physical medical glove, not an AI/ML diagnostic tool. There are no human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This concept is not applicable as the device is a physical medical glove and not 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 tests defined by international and national standards such as ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, and ISO 10993-10. These standards define the physical, chemical, and biological properties a glove must possess to be considered safe and effective.
8. The sample size for the training set:
This concept is not applicable. This is a physical product, not a software algorithm that requires a training set.
9. How the ground truth for the training set was established:
This concept is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
August 6, 2021
PingAn Medical Products Co.,Ltd. % Mr. Boyle Wang Designated Submission Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Contact Address
Re: K210725
Trade/Device Name: Nitrile Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 6, 2021 Received: May 12, 2021
Dear Mr. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210725
Device Name Nitrile Patient Examination Glove
Indications for Use (Describe)
The Nitrile Patient Examination Glove is a disposable device intended for medical 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 (K210725)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
PingAn Medical Products Co.,Ltd. Name: Address: Zheji road ,High-tech Industrial Zone of Hukou County, Jiujiang City, Jiangxi Province,332500 China. Phone Number: +86-19931401105 Contact: Zhou Ziyu Date of Preparation: Aug.6,2021
Designated Submission Correspondent
Mr. Boyle Wanq 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 Patient Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS,S, M, L, XL
3.0 Classification_
Production code: LZA Requlation number: 21CFR880.6250 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/ Blue/ Black/ Pink Color 510(k) number: K171422
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5.0 Indication for Use
The Nitrile Patient Examination Glove 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 subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
7.0 Technological Characteristic ComparisonTable
| Item | Subject Device(K210725) | Predicate Device(K171422) | Comparison |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile PatientExamination Gloveis 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 andquantity, NitrileGlove Powder | Single-useindication, powderfree, device color,device name, glovesize and quantity,Disposable PowderFree Nitrile | Same |
Table1-General Comparison
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| Free Blue, Non- | Examination Glove, | |
|---|---|---|
| Sterile | Non-Sterile |
Table2 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 | ||||||
| Subject Device(K210725) | Designation | Size | Tolerance | |||||
| XS | S | M | L | XL | ||||
| Length, mm | 220 | 220 | 230 | 230 | 230 | min | ||
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Remark | SIMILAR |
Analysis: The physical dimensions are little different with that of the predicate, but they all meet the requirements of ASTM D6319-19.
Table3 Performance Comparison
| Item | Subject device(K210725) | Predicate device(K171422) | Comparison | ||
|---|---|---|---|---|---|
| Colorant | Blue | White/ Blue/Black/ Pink | Same | ||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | 14MPa, min | Same |
| UltimateElongation | 500% min | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa, min | 14MPa, min | Same | |
| UltimateElongation | 400%min | 400%min | Same | ||
| Comply with ASTM D6319 | Comply withASTMD6319 | Same | |||
| Freedom from Holes | Be free fromholes when | Be free fromholes when | Same |
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| tested inaccordance withASTMD5151AQL=2.5 | tested inaccordance withASTMD5151AQL=2.5 | ||
|---|---|---|---|
| Powder Content | Meet therequirements ofASTM D6124 | Meet therequirements ofASTM D6124 | Same |
Table4 Safety Comparison
| Table4 Safety Comparison | |||
|---|---|---|---|
| Item | Subject device (K210725) | Predicate device (K171422) | Comparison |
| Material | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) | Under the conditions of the study, not an irritant | |
| Sensitization (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) | Under conditions of the study, not a sensitizer. | Comply with ISO10993-10 | |
| Cytotoxicity (ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity) | Under conditions of the study, device extract is not cytotoxic | / |
8.0 Discussion of Non-clinical and Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all
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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 D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
| TestMethodology | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| ASTM D6319 | PhysicalDimensionsTest | Length(mm):XS/S: ≥220;M/L/XL: ≥230.Width(mm):XS: 70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10;Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | Length(mm):>230Width(mm):XS: 77-79S: 81-84M: 88-91L: 103-107XL: 111-115PassFinger: 0.08-0.09Palm: 0.08-0.09Pass | |
| ASTM D5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTMD5151 AQL 2.5 | 0/125 leaksPass | |
| ASTM D6124 | Powder Content | Meet the requirements of ASTMD6124 < 2.0mg | 0.01(mg/glove)Pass | |
| ASTM D412 | Physicalproperties | BeforeAging | TensileStrength≥14MPa | 15.0-17.9Pass |
| UltimateElongation≥500% | 533-553Pass | |||
| AfterAging | TensileStrength≥14MPa | 15.8-17.4Pass | ||
| UltimateElongation≥400% | 532-550Pass | |||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions ofthe study, did not |
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| show potential toxicityto L-929 cells.Pass | |||
|---|---|---|---|
| ISO 10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant.Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer.Pass |
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 subject 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.