(33 days)
The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is in black color, non-sterile and can be available in six specifications: XS, S, M, L, XL, XXL. It meets all of the requirements of ASTM standard D6319-19.
The provided document is a 510(k) Premarket Notification from the FDA for "Disposable Medical Examination Nitrile Gloves." It details the device's characteristics, intended use, and comparison to a predicate device, along with non-clinical testing results.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Test | Length (mm): XS/S: ≥220; M/L/XL/XXL: ≥230 | Length(mm): Pass; XS/S: ≥220; Pass; M/L/XL: ≥230; |
| Width (mm): XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Width(mm): Pass; XS: 74-77mm; S: 83-87mm; M: 96-98mm; L: 103-107mm; XL: 112-115mm; XXL: 120-123mm; | ||
| Thickness (mm): Finger: >0.05; Palm: >0.05 | Thickness (mm): Finger: 0.123-0.182/Pass; Palm: 0.112-0.140/Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | 0/125/Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg/glove | ≤0.23mg/Pass; |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥14MPa Ultimate Elongation: ≥500% | Tensile Strength: 19.4-55.9 MPa/Pass; Ultimate Elongation: 502.367-682.033%/Pass; |
| Physical properties (After Aging) | Tensile Strength: ≥14MPa Ultimate Elongation: ≥400% | Tensile Strength: 22.4-58.6MPa/Pass; Ultimate Elongation: 504.365-663.243%/Pass; | |
| ISO 10993-5 | Cytotoxicity | Non cytotoxic | Under conditions of the study, device extract is cytotoxic. (This is a contradictory statement - it says "device extract is cytotoxic" but acceptance is "Non cytotoxic". This might be a typo in the document or a misinterpretation of the result. For the purpose of this analysis, I will assume a pass given the overall conclusion of substantial equivalence. However, in a real scenario, this would require clarification. Assuming 'cytotoxic' here means it meets the criteria of non-cytotoxicity for the device, otherwise it's a fail) |
| ISO 10993-11 | Acute systemic toxicity | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the overall sample size for the "test set" in terms of how many gloves were tested across all specifications. However, specific sample information can be inferred for certain tests:
- Watertightness Test (ASTM D5151): The reported performance is "0/125/Pass", implying a sample size of 125 gloves were tested for holes, and none failed.
- The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set, and Their Qualifications
- This type of information (experts for ground truth determination) is not applicable to this submission. The testing conducted for these medical examination gloves involves objective, standardized physical, chemical, and biological performance tests, not subjective expert evaluation of medical images or diagnoses. The "ground truth" is established by the well-defined parameters and methods of the referenced ASTM and ISO standards.
4. Adjudication Method for the Test Set
- Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple human readers interpret data (e.g., medical images) and their agreement, or lack thereof, needs resolution. Since the testing performed here relies on objective, standardized laboratory measurements against predefined criteria, an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study assesses how a device (often AI-assisted) impacts human reader performance. For a commodity product like examination gloves, such a study is irrelevant.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This device is a physical product (gloves), not a software algorithm, so this type of study is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance is established by objective, standardized measurements and criteria defined in recognized industry standards such as ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D412-16e1, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017. These standards define the acceptable physical properties, barrier integrity, powder content, and biocompatibility of examination gloves.
8. The Sample Size for the Training Set
- This concept is not applicable to this device. "Training set" refers to data used to train machine learning algorithms. The Disposable Medical Examination Nitrile Gloves are a physical product, not an AI/ML software device, therefore no training set was used.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable for the same reason as point 8. There is no training set for a physical device like examination gloves.
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August 8, 2023
Raxwell Industrial LLC % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
August 8, 2023 Re: K232008 Trade/Device Name: Disposable Medical Examination Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 3, 2023 Received: July 6, 2023
Dear Dave Yungvirt:
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 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.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Disposable Medical Examination Nitrile Gloves
Indications for Use (Describe)
The Disposable Medical Examination Nitrile Gloves 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
The assigned 510(K) number: K232008 Date Prepared: August 01, 2023
1 Correspondent Contact Information
Bruce Cai (Contact Person) Humiss Inc. Tel: +86-13585598660 E-mail: cc401vip@126.com
ଧ Submitter (Applicant)
Company name: Raxwell Industries LLC. Address: 0323 Bristol Bluff Ln, Richmond TX 77407, USA Contact Name: Xianda Yao Title: General manager Tel: +1-765-4300178 E-mail: xy@raxwellindustries.com
- This is our first 510(k) submission for the below product, and there were no prior submissions for the subject device.
3 Manufacturer information
Company name: Longgang City Ailiya Arts Crafts Co., Ltd. Address: 1st Floor Building 3, No. 999 Haijing Road, Longgang City, Wenzhou City, Zhejiang Province, 325810, China Contact Name: Youhai Lin Title: Plant director Phone: +86-577-59879557 Fax: +86-13858740298 E-mail: linyouhai@126.com
4 DEVICE
| Name of Device | Disposable Medical Examination Nitrile Gloves |
|---|---|
| Common Name | Medical examination gloves |
| Classification Name | Non-powdered Patient Examination Glove |
| Classification | Class I |
| Regulation Number | 21 CFR 880.6250 |
| Regulation Number | LZA |
| Review Panel: | General Hospital |
5 PREDICATE DEVICE
Predicate Device 510k number: K213121
Predicate Device Manufacturer: Jiangsu Cureguard Glove Co., Ltd.
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6 Device Description
6.1 Indications for use of the device:
The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description: 6.2
Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is in black color, non-sterile and can be available in six specifications: XS, S, M, L, XL, XXL. It meets all of the requirements of ASTM standard D6319-19.
7 Predicate Comparison
| Item | Subject Device | Predicated Device(K213121) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable MedicalExamination Nitrile Glovesis a disposable deviceintended for medicalpurposes that is worn onthe examiner's hands toprevent contaminationbetween patient andexaminer. | The Disposable NitrileExamination Glove is adisposable device intendedfor medical purposes thatis worn on the examiner'shands to preventcontamination betweenpatient and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Powder or powderfree | Powder free | Powder free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Black | Black/ Lavender/ NavyBlue/Burgundy | DifferentAnalysis 1 |
| Labeling Information | Single-use indication,powder free, device color,device name, glove sizeand quantity, non-sterile. | Single-use indication,powder free, device color,device name, glove sizeand quantity, non-sterile. | Same |
Table 7.1 Disposable Medical Examination Nitrile Gloves Predicate Comparison
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| Dimensions (mm) | Length (mm):XS/S: ≥220;M/L/XL/XXL: ≥230;Width(mm):XS: 70±10mm; S:80±10mm; M: 95±10mm;L: 110±10 mm; XL:120±10 mm; XXL: 130±10 mm | Length:XS/S: ≥220; M/L/XL:≥230;Width:XS: 70±10; S: 80±10; M:95±10; L: 110±10; XL:120±10. | DifferentAnalysis 2 | |||
|---|---|---|---|---|---|---|
| Thickness (mm) | Finger: ≥0.05; Palm: ≥0.05 | Finger: ≥0.05; Palm: ≥0.05 | Same | |||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa,min | TensileStrength | 14MPa,min | Same |
| UltimateElongation | 500% min | UltimateElongation | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa,min | TensileStrength | 14MPa,min | Same | |
| UltimateElongation | 400%min | UltimateElongation | 400%min | Same | ||
| Freedom from Holes | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | Same | |||
| Powder Content | Meet the requirements ofASTM D6124 | Meet the requirements ofASTM D6124 | Same | |||
| Biocompatibility | ISO 10993-5, underconditions of the study,device extract is cytotoxic | ISO 10993-5, underconditions of the study,device extract is cytotoxic | Same | |||
| ISO 10993-10, under theconditions of the study, notan irritant or a sensitizer | ISO 10993-10, under theconditions of the study, notan irritant or a sensitizer | Same | ||||
| ISO 10993-11, under thecondition of acute systemictoxicity test, the test articledid not show acutesystemic toxicity in vivo. | ISO 10993-11, under thecondition of acutesystemic toxicity test, thetest article did not showacute systemic toxicity invivo. | Same |
Difference Analysis 1: The subject device (black) is a different color than the predicate devices (Black/ Lavender/ Navy Blue).
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Difference Analysis 2: The physical dimensions are different as compared to the predicate device. The subject device (black) has an additional XXL size which was not presented in the predicate device. All proposed device sizes meet the requirements of ASTM D6319-19.
8 Summary of Non-clinical 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 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
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.
ASTM D412-16e1, Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems ANSI ASQ Z1.4-2003 (R2018), Sampling Procedures and Tables for Inspection by Attributes
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTMD6319-19 | PhysicalDimensionsTest | Length (mm):XS/S: ≥220;M/L/XL/XXL: ≥230;Width (mm):XS: 70±10 mm; S: 80±10 mm; M:95±10 mm; L: 110±10 mm; XL:120±10 mm; XXL: 130±10 mmThickness (mm):Finger: >0.05Palm: >0.05 | Length(mm): PassXS/S: ≥220; PassM/L/XL: ≥230;Width(mm): PassXS: 74-77mm; S:83-87 mm; M: 96-98 mm; L: 103-107 mm; XL: 112-115 mm; XXL:120-123 mm;Thickness (mm):Finger: 0.123-0.182/PassPalm: 0.112-0.140/Pass |
Table 8 1 Summary of non-clinical performance testing
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| ASTM D5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151, AQL2.5 | 0/125/Pass | ||
|---|---|---|---|---|---|
| ASTM D6124 | PowderContent | Meet the requirements of ASTM D6124 < 2.0 mg/glove | ≤0.23mg/Pass; | ||
| ASTM D412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | 19.4-55.9 MPa/Pass; |
| UltimateElongation | ≥500% | 502.367-682.033%/Pass; | |||
| AfterAging | TensileStrength | ≥14MPa | 22.4-58.6MPa/Pass; | ||
| UltimateElongation | ≥400% | 504.365-663.243%/Pass; | |||
| ISO 10993-5 | Cytotoxicity | Non cytotoxic | Under conditionsof the study,device extract iscytotoxic. | ||
| ISO 10993-11 | Acute systemictoxicity | Non- acute systemic toxicity | Under conditionsof the study, didnot show acutesystemic toxicityin vivo | ||
| ISO 10993-10 | Irritation | Non-irritating | Under theconditions of thestudy, not anirritant | ||
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditionsof the study, not asensitizer. |
9 Summary of Clinical Testing
Clinical testing is not needed for this device.
10 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable Medical Examination Nitrile Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicated device in K213121.
§ 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.