(58 days)
Powder Free Nitrile Examination Gloves, Orange is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Orange are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile latex and are powder free. They are ambidextrous. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) summary for the Powder Free Nitrile Examination Gloves, Orange, and it describes a non-clinical study to demonstrate substantial equivalence to a predicate device, not a study to prove the device meets acceptance criteria for a new medical device technology. Therefore, many of the requested elements for a study proving device performance (e.g., sample size for test set, ground truth, MRMC study, training set information) are not applicable or not provided in the context of this regulatory submission.
However, I can extract the acceptance criteria and reported performance for the non-clinical tests conducted to support the device's substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests):
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Length | Minimum 230mm | All sizes ≥ 230mm |
| ASTM D6319-19 | Palm Width (XS) | 70 ± 10mm | 76-78mm |
| ASTM D6319-19 | Palm Width (S) | 80 ± 10mm | 86-88mm |
| ASTM D6319-19 | Palm Width (M) | 95 ± 10mm | 96-98mm |
| ASTM D6319-19 | Palm Width (L) | 110 ± 10mm | 106-108mm |
| ASTM D6319-19 | Palm Width (XL) | 120 ± 10mm | 116-118mm |
| ASTM D6319-19 | Palm Width (XXL) | 130 ± 10mm | 126-128mm |
| ASTM D6319-19 | Thickness (Finger) | 0.05mm (min) | 0.15-0.18mm |
| ASTM D6319-19 | Thickness (Palm) | 0.05mm (min) | 0.16-0.22mm |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, Before Aging | 14MPa, min | 15.8-19.9Mpa |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, After Accelerated Aging | 14MPa, min | 15.2-18.8Mpa |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, Before Aging | 500%, min | 500-550% |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 400%, min | 430-500% |
| ASTM D5151-19, ASTM D6319-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL 2.5 requirements |
| ASTM D6124-06(2017), ASTM D6319-19 | Powder-Content | ≤ 2 mg per glove | 0.55-0.78 mg |
| ISO 10993-10:2010 | Biocompatibility: Primary Skin Irritation | Not an irritant | Under conditions of the study, not an irritant |
| ISO 10993-10:2010 | Biocompatibility: Dermal Sensitization | Not a sensitizer | Under conditions of the study, not a sensitizer |
| ISO 10993-5:2009 | Biocompatibility: Cytotoxicity | Cytotoxicity concern addressed by acute systematic toxicity testing | Test article extract showed potential toxicity to L929 cells, concern addressed by acute systematic toxicity testing |
| ISO 10993-11:2017 | Biocompatibility: Acute Systemic Toxicity | No systemic toxicity | Extracts (polar and non-polar) did not show any systemic toxicity |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes (number of gloves or tests) for each non-clinical test conducted. It only reports the ranges of performance achieved.
- Data Provenance: The data is from non-clinical tests performed by Shanxi Hongjin Plastic Technology Co., Ltd. for their device Powder Free Nitrile Examination Gloves, Orange. The type of data is laboratory test results. No country of origin for the data is explicitly stated beyond the manufacturing company's location in China. The tests are prospective in the sense that they were conducted for this specific device to meet regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. These are non-clinical material and performance tests, not clinical studies requiring expert ground truth for interpretation of medical data. The "ground truth" is defined by the technical specifications and standards (e.g., ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study involving human readers or adjudicators for diagnosis. The tests are objective measurements against defined standards.
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 not an AI-assisted device, nor a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for these tests is based on established industry standards (ASTM D6319-19, ASTM D412-16, ASTM D5151-19, ASTM D6124-06(2017)) and international biocompatibility standards (ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-11:2017). These standards specify the test methods and the acceptable ranges for the physical, chemical, and biological properties of examination gloves.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. As above, this does not involve a training set for an algorithm.
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March 26, 2022
Shanxi Hongjin Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K220229
Trade/Device Name: Powder Free Nitrile Examination Gloves, Orange Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 20, 2022 Received: January 27, 2022
Dear Kathy Liu:
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) K220229
Device Name
Powder Free Nitrile Examination Gloves, Orange
Indications for Use (Describe)
Powder Free Nitrile Examination Gloves, Orange is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Shanxi Hongjin Plastic Technology Co., Ltd.
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
The assigned 510(K) number: K220229 Date Prepared: January 20, 2022
1. Owner's Identification:
Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
Tel: 86-311-66766067 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: 909-590-1611 Email: kathyliu@hongrayusa.com or fdareg@126.com
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Gloves, Orange Common Name: Patient Examination Gloves Classification Name: Patient Examination Glove Classification Regulation: 21 CFR 880.6250 Product Code: LZA Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Wrp Asia Pacific Sdn Bhd Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) (K192635)
4. Device Description:
Powder Free Nitrile Examination Gloves, Orange are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile latex and are powder free. They are ambidextrous. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
5. Indications for Use:
Powder Free Nitrile Examination Gloves, Orange is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Comparison of Subject Device and Predicate Device: 6.
The subject device will be known as Powder Free Nitrile Examination Gloves, Orange. The following tables are summaries of the technological characteristics, biocompatibility of the subject and predicate devices.
| Characteristics | Standards | Subject DeviceK220229 | Predicate DeviceK192635 | ComparisonAnalysis |
|---|---|---|---|---|
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same |
| Color | - | Orange | Orange | Same |
| Texture | - | Hand textured | Hand textured | Same |
| Trade Name | - | Powder Free NitrileExamination Gloves,Orange | Powder Free Nitrile PatientExamination Gloves, Non-Sterile (Orange) | Similar |
| Product Code | - | LZA | LZA | Same |
General Comparison Table:
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Shanxi Hongjin Plastic Technology Co., Ltd.
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
| Regulation Number | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
|---|---|---|---|---|
| Class | I | I | Same | |
| Physical PropertiesBefore AgingTensile Strength:Ultimate Elongation:After AgingTensile Strength:Ultimate Elongation : | ASTM D6319-19 | 14MPa min500% min14MPa min400% min | 14MPa min500% min14MPa min400% min | Same |
| Thickness- Finger- Palm | ASTM D6319-19 | 0.16-0.22mm0.15-0.18mm | 0.21-0.23mm0.19-0.22mm | Different |
| Powder Free | ASTM D6124–06(2017) | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| BiocompatibilityPrimary Skin IrritationTest | ISO 10993-10:2010 | Under conditions of the study,not an irritant | Not a primary skin irritant | Same |
| BiocompatibilityDermal SensitizationStudy | ISO 10993-10:2010 | Under conditions of the study,not a sensitizer | Not a contact sensitizer | Same |
| BiocompatibilityCytotoxicity | ISO 10993-5:2009 | Under the conditions of thisstudy, the test article extractshowed potential toxicity toL929 cells.Cytotoxicity concern wasaddressed by acute systematictoxicity testing. | Exhibit severe cytotoxicityreactivity at 100%, 66%, and44% extract concentration.Moderate cytotoxicityreactivity at 30%, mildcytotoxicity reactivity at20% and slight cytotoxicityreactivity at 15% extractconcentrations.Cytotoxicity concern wasaddressed by acute systematictoxicity testing. | Same |
| Biocompatibility AcuteSystemic Toxicity | ISO 10993-11:2017 | It is concluded that the extracts(polar and non-polar) of theproduct did not show anysystemic toxicity | It is concluded that the extracts(polar and non -polar) of theproduct did not show anysystemic toxicity | Same |
| Watertight (1000ml) | ASTM D5151-19 | Inspection Level 1, AQL 2.5 | Inspection Level 1, AQL 1.5 | Similar |
| Indications for Use | - | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | Same |
| Size | Medical GloveGuidance Manual– Labeling | XS, S, M, L, XL, XXL | XS, S, M, L, XL | Similar |
| Single use | Medical GloveGuidance Manual– Labeling | Single use | Single use | Same |
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for size and thickness. The subject device is one more extra size XXL and thinner than predicate device.
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Shanxi Hongjin Plastic Technology Co., Ltd.
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County,
Linfen City, Shanxi Province
510(K) SUMMARY
7. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards: The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below.
| Test method | Purpose | Acceptance Criteria | Results | Status |
|---|---|---|---|---|
| ASTM D6319-19 | Length | Minimum 230mm | All size ≥230 | Pass |
| ASTM D6319-19 | Palm Width | XS: 70±10mm | 76-78mm | Pass |
| S: 80±10mm | 86-88 mm | Pass | ||
| M:95±10mm | 96 -98mm | Pass | ||
| L:110±10mm | 106-108 mm | Pass | ||
| XL: 120±10mm | 116-118 mm | Pass | ||
| XXL: 130±10mm | 126-128 mm | Pass | ||
| ASTM D6319-19 | Thickness | Finger: 0.05mm (min) | 0.15-0.18mm | Pass |
| Palm: 0.05mm (min) | 0.16-0.22mm | Pass | ||
| ASTM D6319-19ASTN D412-16 | Tensile Strength, BeforeAging | 14MPa, min | 15.8-19.9Mpa | Pass |
| ASTM D6319-19ASTN D412-16 | Tensile Strength, AfterAccelerated Aging | 14MPa, min | 15.2-18.8Mpa | Pass |
| ASTM D6319-19ASTN D412-16 | Ultimate Elongation, BeforeAging | 500%, min | 500-550% | Pass |
| ASTM D6319-19ASTN D412-16 | Ultimate Elongation, AfterAccelerated Aging | 400%, min | 430-500% | Pass |
| ASTM D 5151-19ASTM D6319-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5requirements | Pass |
| ASTM D 6124-06(2017)ASTM D6319-19 | Powder-Content | ≤ 2 mg per glove | 0.55-0.78 mg | Pass |
8. Summary of Clinical Testing
No Clinical study is included in this submission.
Conclusion: 9.
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device, K192635.
§ 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.