(60 days)
The Nitrile Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger 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 document is a 510(k) Premarket Notification for a Nitrile Glove, which is a Class I medical device. Therefore, the "device" in this context is a physical product (a medical glove), not a software or AI-driven diagnostic tool. The questions you've asked are highly relevant to the evaluation of AI/ML-based medical devices, specifically regarding their performance on test sets, ground truth establishment, and clinical studies.
Since the document describes a physical medical device (nitrile glove) and not an AI or software device, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context relate to physical properties, performance standards, and biocompatibility rather than diagnostic accuracy, reader studies, or training sets for AI models.
Therefore, I cannot extract the information requested in your prompt because it pertains to a different type of medical device (AI/ML) than what is described in the provided text.
However, I can extract the acceptance criteria and performance data relevant to this specific device (Nitrile Glove) as described in the document.
Acceptance Criteria and Device Performance for a Nitrile Glove
The document details performance testing for the Nitrile Glove based on established ASTM and ISO standards for examination gloves.
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm):- S: ≥220- M/L/XL: ≥230Width (mm):- S: 80±10- M: 95±10- L: 110±10- XL: 120±10Thickness (mm):- Finger: ≥0.05- Palm: ≥0.05 | Length:- S: >220/Pass- M/L/XL: >230/PassWidth:- S: 81-85 /Pass- M: 91-96/ Pass- L: 102-106/ Pass- XL: 114-116/PassThickness:- Finger: 0.06-0.08/Pass- Palm: 0.07-0.08/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 | 0.02mg/Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Tensile Strength: 15-18/PassUltimate Elongation: 530-560/Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | Tensile Strength: 15-18/PassUltimate Elongation: 530-555/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 |
Since the requested questions (2-9) are specific to AI/ML device evaluations and are not applicable to the physical medical device (Nitrile Glove) described in the provided FDA submission, I cannot provide answers for those. The document explicitly states: "Clinical testing is not needed for this device." and discusses non-clinical and performance testing related to material integrity, physical dimensions, and biological safety for a physical product.
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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.
June 25, 2021
Jiangsu Dihong Industry and Trade Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211252
Trade/Device Name: Nitrile Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 2, 2021 Received: April 26, 2021
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/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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211252
Device Name Nitrile Glove
Indications for Use (Describe)
The Nitrile Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K211252)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information_
Name: Jiangsu Dihong Industry and Trade Co.,Ltd. Address: Dongxiaodian Industrial Park, Shuyang City, Jiangsu, China Phone Number: Sue Chen Contact: Date of Preparation:
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 Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S,M,L,XL
3.0 Classification
Production code: LZA Regulation 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
510(k) number. K171422
5.0 Indication for Use
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The Nitrile Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger 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(K211252) | Predicate Device(K171422) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile Glove isa non-steriledisposable deviceintended for medicalpurposes that isworn on theexaminer's hands orfinger to preventcontaminationbetween patient andexaminer. | The Nitrile PowderFree patientexamination glove isa non-steriledisposable deviceintended for medicalpurposes that isworn on theexaminer's hands orfinger to 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, glovesize and quantity,Nitrile GlovePowder Free Blue,Non-Sterile | Single-useindication, powderfree, device color,device name, glovesize and quantity,Disposable PowderFree NitrileExamination Glove,Non-Sterile | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
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| Designation | Size | Tolerance | ||||||
|---|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | ||||
| PredicateDevice(K171422) | Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ | ||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Designation | Size | |||||||
| Subject Device(K211252) | S | M | L | XL | Tolerance | |||
| Length, mm | 220 | 230 | 230 | 230 | min | |||
| Width, mm | 80 | 95 | 110 | 120 | $\pm 10$ | |||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Remark | Similar |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19
| Item | Subject device(K211252) | Predicate device(K171422) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | White/ Blue/Black/ Pink | Same | ||
| PhysicalProperties | BeforeAging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 500% min | 500% min | Same | ||
| AfterAging | Tensile Strength | 14MPa, min | 14MPa, min | Same | |
| Ultimate Elongation | 400%min | 400%min | Same | ||
| Comply with ASTM D6319 | Comply withASTM D6319 | Same | |||
| Freedom from Holes | Be free from holes whentested inaccordance withASTMD5151AQL=2.5 | Be free from holes whentested inaccordance withASTMD5151AQL=2.5 | Same |
Table3 Performance Comparison
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| Powder Content | 0.02 mg per glove, Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same |
|---|---|---|---|
| ---------------- | -------------------------------------------------------- | ------------------------------------- | ------ |
Table4 Safety Comparison
| Item | Subjectdevice(K21152) | Predicatedevice(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 | Comply withISO10993- 10 | Same |
| Sensitization (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests forIrritation And SkinSensitization) | Underconditions ofthe study, nota sensitizer. | |||
| Cytotoxicity(ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests for InVitro Cytotoxicity) | Underconditions ofthestudy,device extractis not cytotoxic | / | Similar |
8.0 Discussion of Non-clinical and Performance Testing
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.
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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.
| TestMethod | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTMD6319 | PhysicalDimensionsTest | Length(mm):S:≥220;M/L/XL:≥230;Width(mm):S: 80±10;M: 95±10;L: 110±10;XL: 120±10; | Length:S:>220/Pass;M/L/XL: >230/Pass;Width:S: 81-85 /PassM: 91-96/ PassL: 102-106/ PassXL:114-116/Pass |
| Thickness (mm) :Finger: ≥0.05Palm: ≥0.05 | Finger: 0.06-0.08/PassPalm: 0.07-0.08/Pass | ||
| ASTMD5151 | Watertightness Test forDetection ofHoles | Meet the requirements of ASTMD5151 AQL 2.5 | 0/125 leaks /Pass |
| ASTMD6124 | PowderContent | Meet the requirements of ASTMD6124 < 2.0mg | 0.02mg/Pass |
| ASTMD412 | Physicalproperties | BeforeAgingTensileStrength | ≥14MPa15-18/Pass |
| BeforeAgingUltimateElongation | ≥500%530-560/Pass | ||
| AfterAgingTensileStrength | ≥14MPa15-18/Pass | ||
| AfterAgingUltimateElongation | ≥400%530-555/Pass | ||
| ISO10993-5 | Cytotoxicity | Non-cytotoxic | Underconditionsofthe study, didnotshowpotentialtoxicityto L-929cells./Pass |
| ISO10993-10 | Irritation | Non-irritating | Under theconditions ofthe study, notan irritant/Pass |
| ISO10993-10 | Sensitization | Non-sensitizing | Underconditions ofthe study, not asensitizer./Pass |
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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 under K171422 .
§ 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.