(92 days)
The Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Disposable Nitrile Gloves are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue or black color, powder free, nitrile ambidextrous gloves. The gloves are offered in large (L) size, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.
The provided text describes the 510(k) premarket notification for Disposable Nitrile Gloves (ABC-DG01). It outlines the device's characteristics, its intended use, and a comparison to a predicate device (K171422). The submission focuses on demonstrating substantial equivalence through non-clinical testing.
Here's an analysis of the provided information to address your request:
Based on the provided document, the "device" in question is Disposable Nitrile Gloves (ABC-DG01). This is a Class I medical device, meaning it is considered low risk and subject to general controls. The acceptance criteria and "study" described are for physical and chemical performance, not for a diagnostic algorithm or AI.
Therefore, many of the questions regarding AI-specific studies (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.
The "study" refers to non-clinical performance testing conducted to demonstrate that the Disposable Nitrile Gloves meet established standards for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The relevant information is found in "Table 4. Performance Comparison" and "Summary of Non-Clinical Testing" (specifically the table under section G).
| Test Method (Acceptance Criteria) | Purpose | Acceptance Criteria (K230542) | Reported Device Performance (K230542) (Blue & Black) |
|---|---|---|---|
| Dimensions (ASTM D6319-19) | Evaluate the physical dimension of the glove | Width 110 ±10mm Length 230mm min Palm - 0.05mm min. Finger - 0.05mm min. | Pass 106mm min width 250mm min length Palm – 0.06mm min. Finger – 0.12mm min |
| Physical properties (ASTM D6319-19) | Evaluate the tensile strength and ultimate elongation before and after aging | Tensile Strength: Before Aging ≥ 14 MPa, min. After Aging ≥ 14 MPa, min. Elongation: Before Aging 500%, min. After Aging 400%, min. | Pass Tensile Strength: Before Aging 19.07MPa, min. After Aging 18.11 MPa, min. Elongation: Before Aging 586.47%, min. After Aging 469.20%, min. |
| Freedom from holes (ASTM D5151-19) | Detect holes in the gloves | No leakage at sampling level of G-1, AQL 2.5 | Pass No leakage, 125 of 125 passed of each color |
| Residual Powder (ASTM D6124-06) | Detect the powder residue in the glove | <2mg per glove | Pass average 0.07 mg per glove |
2. Sample size used for the test set and the data provenance
The document provides some direct sample sizes for specific tests:
- Freedom from holes: "125 of 125 passed of each color" (meaning 125 blue gloves and 125 black gloves were tested).
- For other tests like Dimensions, Physical properties, and Residual Powder, specific sample sizes are not explicitly stated in the provided text, but the results indicate that a sample was tested according to the ASTM standards.
- Data provenance: Not explicitly stated, but given the company location (Huizhou, China), the testing was likely conducted in China, often by accredited labs specializing in material testing. The data is retrospective in the sense that it was collected as part of product verification before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a physical product (gloves), not a diagnostic algorithm where expert consensus establishes "ground truth." The "ground truth" for these tests are the objective measurements against the specified ASTM standards.
4. Adjudication method for the test set
Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for a diagnostic outcome. The tests are objective measurements (e.g., measuring thickness, tensile strength, liquid leakage, residual powder mass). The results pass or fail based on the numerical comparison to the acceptance criteria.
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
Not Applicable. This is for a physical medical product (gloves), not an AI/Software as a Medical Device (SaMD). No "human readers" or "AI assistance" are involved in the performance testing of gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is for a physical medical product (gloves), not an AI/SaMD. There is no algorithm.
7. The type of ground truth used
The "ground truth" for these physical and chemical tests is defined by the objective measurement against established engineering standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06). For example, for "freedom from holes," the ground truth is simply whether liquid leaks or not according to the specified test method. Similarly, for "tensile strength," the ground truth is the measured force required to break the glove.
8. The sample size for the training set
Not Applicable. This is not an AI/machine learning device. No "training set" is used.
9. How the ground truth for the training set was established
Not Applicable. As above, no training set or AI model is involved.
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May 31, 2023
Huizhou Anboson Technology Co., Ltd. % Ivv Wang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai. 200122 China
Re: K230542
Trade/Device Name: Disposable Nitrile Gloves (ABC-DG01) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 5, 2023 Received: May 5, 2023
Dear Ivy 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 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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Indications for Use
510(k) Number (if known) K230542
Device Name Disposable Nitrile Gloves (ABC-DG01 )
Indications for Use (Describe)
The Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand 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
(As requirement by 21 CFR 807.92)
K230542
Date prepared: 2023-05-05
A. Applicant:
Name: Huizhou Anboson Technology Co., Ltd.
Address: 2F, No.7, Hechang East Fourth Road, Zhongkai High-tech Zone, Huizhou City, Guangdong, 516001 China
Contact: Ms. Xuanli Weng Title: Manager Tel: +86-752-2607756
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Disposable Nitrile Gloves Common Name: Nitrile Patient Examination Gloves (Powder Free) Model: ABC-DG01
Regulatory Information Classification Name: Non-powdered patient examination glove Classification: Class I Product code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
C. Predicate device:
K171422 Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color Ever Global (Vietnam) Enterprise Corp
D. Indications for use of the device:
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The Disposable Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
E. Device Description:
The Disposable Nitrile Gloves are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue or black color, powder free, nitrile ambidextrous gloves. The gloves are offered in large (L) size, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.
| Table 1 General Comparison of Proposed and Predicate Devices | |||
|---|---|---|---|
| Device | Proposed Device | Predicate Device | Result |
| 510K # | K230542 | K171422 | - |
| Product Name | Disposable Nitrile Gloves | Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color | - |
| Product Code | LZA | LZA | Same |
| Classification | Class I | Class I | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for use | The Disposable Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | The Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | Same |
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Singe use | Single use | Same |
| Label | Single-use, indication, powder free, device color, device name, glove size and quantity, Disposable Nitrile Glove, Non-Sterile | Single-use, indication, powder free, device color, device name, glove size and quantity, Disposable Powder Free Nitrile Examination Glove, Non- | Same |
Table 1 General Comparison of Proposed and Predicate Devices
F. Summary of Technological Characteristics
Table 2 Device dimension comparison
| Predicatedevice | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL |
Sterile
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| (K171422) | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
|---|---|---|---|---|---|---|---|
| Width, mm | 75 | 85 | 90 | 105 | 115 | $\pm$ 5 | |
| Thickness, mm | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Size | |||||||
| DesignationL | Tolerance | ||||||
| ProposeddeviceK230542 | Length, mm | 230 | min | ||||
| Width, mm | 110 | $\pm$ 10 | |||||
| Thickness, mm | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Result | Similar |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
The proposed device has less size than that of the predicate device, while this difference will not affect the safety or performance of the proposed device.
| Item | Proposeddevice (K230542) | Predicatedevice (K171422) | Result | |||
|---|---|---|---|---|---|---|
| Colorant | Blue/ Black | White/ Blue/ Black/ Pink | Similar | |||
| Physicalproperties | Before aging | Tensile strength | 14MPa, min | 14MPa, min | Same | |
| Ultimate elongation | 500%, min | 500%, min | Same | |||
| After aging | Tensile strength | 14MPa, min | 14MPa, min | Same | ||
| Ultimate elongation | 400%, min | 400%, min | Same | |||
| Comply with ASTM D6319 | Comply with ASTMD6319 | Same | ||||
| Freedom from holes | Be free fromholes whentested inaccordance withASTM D5151G-1, AQL 2.5 | Be free from holes whentested in accordancewith ASTM D5151G-1, AQL 2.5 | Same | |||
| Residual Powder | Meet therequirements ofASTM D6124 | Meet the requirementsof ASTM D6124 | Same |
Table 3 Performance comparison
Analysis: The subject device is available in blue or black color; however, the predicate is available in multiple colors (white, blue, black, pink). Biocompatibility testing was successfully completed for the subject device, demonstrating that any color differences do not affect the safety of the proposed device.
Table 4 Biocompatibility comparison
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| Item | Proposeddevice (K230542) | Predicate device(K171422) | Result | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | IrritationISO 10993-23 | Under the conditions of thestudy, not anirritant. | Comply with ISO10993-10 | Same |
| SensitizationISO 10993-10 | Under theconditions of thestudy, not asensitizer. | |||
| In VitroCytotoxicityISO 10993-5 | Under theconditions of thestudy, the testarticle extractshowedpotential toxicity. | Not available | Different | |
| Acute SystemicToxicityISO 10993-11 | Under theconditions of thestudy, the deviceextract does notinduce acutesystemic toxicityresponse. | Not available | Different |
Analysis: In vitro cytotoxicity and acute systemic toxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment.
G. Summary of Non-Clinical Testing
A Biocompatibility
The following tests for the subject device were conducted the biocompatibility of Disposable Nitrile Gloves:
- ISO 10993-5: In Vitro Cytotoxicity
- ISO 10993-23: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Acute Systemic Toxicity
A Performance Testing
Performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
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- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- 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
| Test Method | Purpose | Acceptance Criteria | Results (Blue & Black) |
|---|---|---|---|
| Dimensions(width)(thickness)ASTMD6319-19 | The purpose of the test is toevaluate the physicaldimension of the glove | Width 110 ±10mmLength 230mm minPalm - 0.05mm min.Finger-0.05mm min. | Pass106mm min width250mm min lengthPassPalm – 0.06mm min.Finger-0.12mm min |
| PhysicalpropertiesASTMD6319-19 | The purpose of the test is toevaluate the tensilestrength and ultimateelongation before and afteraging | Tensile Strength:Before Aging ≥ 14 MPa,min.After Aging ≥ 14 MPa,min.Elongation:Before Aging 500%, min.After Aging 400%, min. | PassTensile Strength:Before Aging 19.07MPa,min.After Aging 18.11 MPa,min.Elongation:Before Aging 586.47%, min.After Aging 469.20%, min. |
| Freedomfrom holesASTM D5151-19 | The purpose of the test is todetect holes in the gloves | No leakage at samplinglevel of G-1, AQL 2.5 | PassNo leakage, 125 of 125passed of each color |
| ResidualPowderASTMD6124-06(Reapproved2017) | The purpose of the test is todetect the powder residuein the glove | <2mg per glove | Passaverage 0.07 mg per glove |
H. Clinical Test Conclusion
No clinical study is included in this submission.
l. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Disposable Nitrile Gloves are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared 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.