(87 days)
The Disposable Nitrile Examination 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. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided document pertains to the 510(k) premarket notification for Nitrile Examination Gloves (K212922). This device is a Class I reserved medical device (non-powdered patient examination glove) and, as such, does not involve AI/ML technology or image analysis.
Therefore, the requested information regarding acceptance criteria, study details, human readers, ground truth establishment, etc., is not applicable to this type of medical device submission. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical properties and biocompatibility.
Here's a breakdown of why each point of your request is not relevant in this context:
- Acceptance Criteria and Reported Device Performance: This device is a physical product (gloves), not an AI/ML system. The acceptance criteria relate to physical and chemical properties like dimensions, tensile strength, freedom from holes, powder content, and biocompatibility, not measures like accuracy, sensitivity, or specificity of an algorithm.
- Sample size for the test set and data provenance: No "test set" in the context of AI/ML models exists. The testing involves physical samples of gloves.
- Number of experts and qualifications for ground truth: No "ground truth" in the AI/ML sense is established. The "ground truth" for gloves is adherence to physical and biocompatibility standards.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI/ML diagnostic or assistive device for human readers.
- Standalone (algorithm-only) performance: Not applicable, as there is no algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is established by adherence to recognized ASTM and ISO standards for glove manufacturing and safety (e.g., ASTM D6319, ASTM D5151, ISO 10993).
- Sample size for the training set: Not applicable, as there is no AI/ML model to train.
- How the ground truth for the training set was established: Not applicable.
Instead, the document details:
1. Acceptance Criteria and Reported Device Performance (Summary of Non-clinical Testing):
The acceptance criteria are derived from recognized standards like ASTM D6319 for physical dimensions, ASTM D5151 for watertightness, ASTM D6124 for powder content, and ASTM D412 for physical properties (tensile strength, ultimate elongation). Biocompatibility tests (ISO 10993-5, -10, -11) also have pass/fail criteria.
| Test Method | Purpose | Acceptance Criteria | Reported Performance / Results |
|---|---|---|---|
| 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 (mm): S/M/L/XL: > 230/PassWidth (mm): S: 80-90 /Pass; M: 85-96/ Pass; L: 101-115/ Pass; XL:110-122/ PassThickness (mm):S: Finger: 0.08-0.15/Pass; Palm: 0.07-0.08/PassM: Finger: 0.10-0.18/Pass; Palm: 0.07-0.11/PassL: Finger: 0.11-0.18/Pass; Palm: 0.07-0.08/PassXL: Finger: 0.11-0.13/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/Pass (This implies 0 failures in a sample of 125, meeting the AQL of 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.12-0.15mg/Pass |
| ASTM D412 | Physical properties | Before Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥500%After Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥400% | Before Aging: Tensile Strength: 16-30MPa/Pass; Ultimate Elongation: 500-549%/PassAfter Aging: Tensile Strength: 14-26MPa/Pass; Ultimate Elongation: 435-525%/Pass |
| ISO 10993-5 | Cytotoxicity | In Vitro Cytotoxicity Test (Pass criteria not explicitly detailed but implied by "Pass" result) | Under conditions of the study, device extract is cytotoxic (This seems to be a typo/inconsistency in the original document, it states "is cytotoxic" but the result is "Pass" for the overall conclusion for the device. It likely meant "not cytotoxic" or a specific grade of cytotoxicity was deemed acceptable within the standard's criteria for a "Pass"). - Self-correction: The predicate device comparison table on page 5 shows "ISO 10993-5 Under conditions of the study, device extract is cytotoxic" for the predicate, and there is no specific result shown for the subject device in that table, only a "/" which typically means "not directly comparable" or "no specific difference noted for comparison". However, in Table 2 (Summary of Non-clinical Perf, page 6), it states "ISO 10993-5 Cytotoxicity - In Vitro Cytotoxicity Test - Pass". This implies the subject device did pass the cytotoxicity test, despite the conflicting statement in the comparison table. Given the final "Conclusion" states the device is as safe and effective, the "Pass" result is the definitive one for the subject device. |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity (Pass criteria not explicitly detailed but implied by "Pass" result) | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating (Pass criteria not explicitly detailed but implied by "Pass" result) | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing (Pass criteria not explicitly detailed but implied by "Pass" result) | Under conditions of the study, not a sensitizer / Pass |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes for each physical test. However, for the ASTM D5151 Watertightness test, it shows "0/125/Pass," indicating a sample size of 125 gloves. The data provenance is presumed to be from the manufacturer (HSK Medical Apparatus Foshan China Co. LTD) based in China, generating the data for this 510(k) submission. These are non-clinical (laboratory) tests, not retrospective or prospective patient data.
3. Experts and Ground Truth Establishment:
Ground truth for physical/biocompatibility tests is established by the specifications defined in the referenced international (ISO) and national (ASTM) standards. These standards are developed by expert committees in their respective fields (e.g., materials science, biological evaluation). There aren't "experts" in the sense of clinical readers establishing ground truth for individual cases; rather, the "experts" are the standards themselves.
4. Adjudication Method:
Not applicable.
5. MRMC Comparative Effectiveness Study:
Not applicable.
6. Standalone Performance:
The performance demonstrated in Table 2 is the "standalone" performance of the physical glove product as measured against the established standards. There is no algorithm.
7. Type of Ground Truth Used:
The ground truth is based on accepted international and national consensus standards (ISO 10993, ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412) for the manufacturing, physical properties, and biocompatibility of examination gloves.
8. Sample Size for Training Set:
Not applicable.
9. How Ground Truth for Training Set was Established:
Not applicable.
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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.
December 10, 2021
HSK Medical Apparatus Foshan China Co. LTD Boyle Wang Official Correspondent Shanghai Truthful information Technology Co., Ltd. RM. 1801.No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K212922
Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: September 2, 2021 Received: September 14, 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.
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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.
For Clarence W. Murray, III, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212922
Device Name Nitrile Examination Gloves
Indications for Use (Describe)
The Disposable Nitrile Examination 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 K212922
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: HSK Medical Apparatus Foshan China Co. LTD Address: Shitang Road, Shishan Town, Nanhai District, Foshan, Guangdong, China. Phone Number: +86 18988689788 Contact: Zhao Zhongheng Date of Preparation: Sept.2, 2021
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Nitrile Examination Gloves 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
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5.0 Indication for Use
The Nitrile Examination 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. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Table1-General Comparison | ||||
|---|---|---|---|---|
| Item | Subject Device(K212922) | Predicated Device(K171422) | Remark | |
| Product Code | LZA | LZA | Same | |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | |
| Class | I | I | Same | |
| Intended Use | The Disposable NitrileExamination Glove is anon-sterile disposabledevice intended formedical purposes that isworn on the examiner'shands or finger toprevent contaminationbetween patient andexaminer. | The Nitrile Powder Freepatient examinationglove is a non-steriledisposable deviceintended for medicalpurposes that is worn onthe examiner's hands orfinger to preventcontamination betweenpatient and examiner. | Same | |
| Material | Nitrile | Nitrile | Same | |
| Powdered orPowered free | Powdered free | Powdered free | Same | |
| Design Feature | Ambidextrous | Ambidextrous | Same | |
| Colorant | Blue | White/Blue/ Black/ Pink | DifferentAnalysis 1 | |
| LabelingInformation | Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile | Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-Sterile | Same | |
| Dimensions(mm) | Length:S: ≥220;M/L/XL: ≥230. | Length:XS/S/M/L/XL: ≥230;Width: | DifferentAnalysis 2 | |
| Width: | XS: 87±5; | |||
| S: 80±10; | S: 85±5; | |||
| M: 95±10; | M: 95±5; | |||
| L: 110±10; | L: 105±5; | |||
| XL: 120±10 | XL: 115±5 | |||
| Thickness(mm) | Finger: ≥0.05; | Finger: ≥0.05; | Same | |
| Palm: ≥0.05 | Palm: ≥0.05 | |||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa,min | Same |
| UltimateElongation | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa,min | Same | |
| UltimateElongation | 400%min | Same | ||
| Freedom fromHoles | Be free from holes whentested in accordancewith ASTMD5151AQL=2.5 | Same | ||
| Be free from holes whentested in accordancewith ASTMD5151AQL=2.5 | ||||
| Powder Content | Meet the requirements ofASTM D6124 | Same | ||
| Biocompatibility | ISO 10993-5Under conditions of thestudy, device extract iscytotoxic | / | ||
| ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizer | Same | |||
| ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo. | / | |||
| N.A. | ||||
| N.A. |
Table1-General Comparison
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Analysis 1: The subject device (Blue) has different color to the predicate device (White/ Blue/ Black/ Pink), but all proposed devices are conducted the biocompatibility test.
Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.
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8.0 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.
| TestMethod | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTMD6319 | PhysicalDimensionsTest | Length(mm): | Length(mm): |
| S: ≥220; | S/M/L/XL: > 230/Pass; | ||
| M/L/XL: ≥230; | Width(mm): | ||
| Width(mm): | S: 80-90 /Pass | ||
| S: 80±10; | M: 85-96/ Pass | ||
| M: 95±10; | L: 101-115/ Pass | ||
| L: 110±10; | XL:110-122/ Pass | ||
| XL: 120±10 | |||
| Thickness (mm): | Thickness (mm): | ||
| Finger: ≥0.05 | S: | ||
| Palm: ≥0.05 | Finger: 0.08-0.15/Pass | ||
| Palm: 0.07-0.08/Pass | |||
| M: | |||
| Finger: 0.10-0.18/Pass | |||
| Palm: 0.07-0.11/Pass | |||
| L: |
Table 2 - Summary of non-clinical performance testing
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| Finger: 0.11-0.18/PassPalm: 0.07-0.08/Pass | |||||
|---|---|---|---|---|---|
| XL:Finger: 0.11-0.13/PassPalm: 0.07-0.08/Pass | |||||
| ASTMD5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151AQL 2.5 | 0/125/Pass | ||
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 < 2.0mg | 0.12-0.15mg/Pass; | ||
| ASTMD412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | 16-30MPa/Pass; |
| UltimateElongation | ≥500% | 500-549%/Pass; | |||
| AfterAging | TensileStrength | ≥14MPa | 14-26MPa/Pass; | ||
| UltimateElongation | ≥400% | 435-525%/Pass; | |||
| ISO10993-5 | Cytotoxicity | In Vitro Cytotoxicity Test | |||
| ISO10993-11 | Cytotoxicity | Non- acute systemictoxicity | Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass | ||
| ISO10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant/ Pass | ||
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer / Pass |
9.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
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10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable Nitrile Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicated device in 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.