(115 days)
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves, Non-sterile. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The document describes the acceptance criteria and study proving the device meets them for Disposable Medical Nitrile Examination Gloves (Non-Sterile) (K211075).
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASMT D6319-19 - Physical Dimensions Test (Width) | Small size: 80 ± 10 mm Medium size: 95 ± 10 mm Large size: 110 ± 10 mm Extra-large size: 120 ± 10 mm | Small size: 82mm (Minimum), 82 mm (Mean), 85 mm (Maximum) Medium size: 91 mm (Minimum), 92 mm (Mean), 93 mm (Maximum) Large size: 108 mm (Minimum), 109 mm (Mean), 110 mm (Maximum) Extra-large size: 121 mm (Minimum), 122 mm (Mean), 125 mm (Maximum) All Passed |
| ASMT D6319-19 - Physical Dimensions Test (Length) | Small size: 220 mm (Minimum) Medium size: 230 mm (Minimum) Large size: 230 mm (Minimum) Extra-large size: 230 mm (Minimum) | Small size: 232 mm (Mean), 230 mm (Minimum) Medium size: 242 mm (Mean), 240 mm (Minimum) Large size: 239 mm (Mean), 237 mm (Minimum) Extra-large size: 243 mm (Mean), 240 mm (Minimum) All Passed |
| ASMT D6319-19 - Physical Dimensions Test (Thickness) | Small size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) Medium size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) Large size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) Extra-large size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) | Small size: Finger – 0.13 mm (Mean), 0.12 mm (Minimum); Palm – 0.08 mm (Mean), 0.08 mm (Minimum) Medium size: Finger – 0.14 mm (Mean), 0.13 mm (Minimum); Palm – 0.09 mm (Mean), 0.08 mm (Minimum) Large size: Finger – 0.14 mm (Mean), 0.13 mm (Minimum); Palm – 0.09 mm (Mean), 0.09 mm (Minimum) Extra-large size: Finger – 0.14 mm (Mean), 0.13 mm (Minimum); Palm – 0.09 mm (Mean), 0.08 mm (Minimum) All Passed |
| ASMT D6319-19 - Physical Requirements Test (Tensile Strength & Elongation) | Before Aging: Tensile Strength 14 MPa (Minimum), Ultimate Elongation 500% (Minimum) After Acceleration Aging: Tensile Strength 14 MPa (Minimum), Ultimate Elongation 400% (Minimum) | Before Acceleration Aging: Tensile Strength 31 MPa (Mean), 17 MPa (Minimum); Ultimate Elongation 563% (Mean), 520% (Minimum) After Acceleration Aging: Tensile Strength 41 MPa (Mean), 28 MPa (Minimum); Ultimate Elongation 555% (Mean), 524% (Minimum) Passed |
| ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes (Water Tight) | AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) - Residual Powder | < 2.0 mg/glove | 1.02 mg/glove Passed |
| ISO 10993-10 - Skin Irritation | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 - Skin Sensitization | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| ISO 10993-5 - In Vitro Cytotoxicity | Under the conditions of study non cytotoxic | Under the condition of the study, the test article showed no cytotoxicity to L-929 cells and cytotoxic level was 0. |
| ISO 10993-11:2017 - Acute Systemic Toxicity | Under the conditions of the study no systemic toxicity | Under the conditions of the study no systemic toxicity |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact "sample size" for each test in terms of the number of individual gloves or test replicates. However, it indicates that the testing was performed according to ASTM D6319-19, which specifies sampling plans and test methods for nitrile examination gloves. For example, for "Freedom from Holes," it refers to an AQL (Acceptance Quality Limit) of 2.5, which is a statistical measure related to sampling.
- Data Provenance: The testing was non-clinical. The specific country of origin for the data is not explicitly stated beyond the manufacturer being in China (Jiangsu Cherish Medical Technology Co., Ltd). The studies are retrospective in the sense that they were conducted on already manufactured gloves.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable as the document describes non-clinical performance testing of a physical medical device (gloves), not a diagnostic algorithm requiring expert ground truth or consensus. The "ground truth" is established by the standardized test methods themselves (e.g., measuring dimensions, tensile strength, presence of holes).
4. Adjudication Method for the Test Set
- This information is not applicable for the reasons stated above. Adjudication methods are typically relevant for human interpretation or AI model performance evaluation against expert-derived ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices often involving human readers or AI algorithms for interpretation, not for examination gloves.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This document evaluates a physical medical device (gloves), not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by standardized test methods and their defined specifications. These include:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10 (Biological Evaluation of Medical Devices – Tests for skin irritation and skin sensitization)
- ISO 10993-5 (Biological Evaluation of Medical Devices – Tests for in vitro cytotoxicity)
- ISO 10993-11:2017 (Biological Evaluation of Medical Devices – Tests for acute systemic toxicity)
8. Sample Size for the Training Set
- Not applicable. This device is a physical product (examination gloves), not an AI/ML model for which "training sets" are used.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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August 5, 2021
Jiangsu Cherish Medical Technology Co., Ltd % Johnson Liu Consultant Cnmed Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia
Re: K211075
Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Non-Sterile) Regulatory Class: 21 CFR 880.6250 Product Code: LZA Dated: July 20, 2021 Received: July 26, 2021
Dear Johnson 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Disposable Medical Nitrile Examination Gloves (Non-Sterile)
Indications for Use (Describe)
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose 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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Image /page/3/Picture/1 description: The image shows the word "Cherish" in a blue, sans-serif font. The word is written in all lowercase letters except for the first letter, which is capitalized. There is a small "TM" symbol in the upper right corner of the word. The word is the main focus of the image and is centered.
510(K) Summary (K211075)
DISPOSABLE MEDICAL NITRILE EXAMINATION GLOVES, NON-STERILE
Preparation Date: August 5th, 2021
1. SUBMITTER
Company Name: JIANGSU CHERISH MEDICAL TECHNOLOGY CO., LTD Company Address: No. 55 Maqianan Chaoyang Road, Jiaoxi Centralized Industrial Zone Changzhou. CN 213000
Contact Person: Johnson Liu Telephone Number: +614-0158-9995 Email: Johnson@cnmed.com.au
2. NAME OF THE DEVICE
Trade Name / Proprietary Name: Cherish Nitrile Examination Gloves Device Name: Disposable Medical Nitrile Examination Gloves (Non-Sterile) Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA
3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE
Predicate Device: K203191 Applicant: Nathan Trading Co., Ltd Device Name: LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital
4. DEVICE DESCRIPTION
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves, Non-sterile. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
5. Indications for Use
Disposable Medical Nitrile Examination Gloves, Non-sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES
| DEVICE PERFORMANCE | |||
|---|---|---|---|
| CHARACTERISTICS | SUBJECT | PREDICATE | REMARKS |
| 510(k) Number | K211075 | K203191 | - |
| Device Name | Disposable Medical NitrileExamination GlovesPowder Free, Non sterile | LYDUS Nitrile ExaminationGloves, Powder Free | - |
| Product Code | LZA | LZA | Same |
| Intended Use/Indications forUse | Disposable Nitrile ExaminationGloves Non-sterile is disposabledevices intended for medical purposethat are worn on the examiner's handto prevent contamination betweenpatient and examiner. The device isfor over the-counter use. | LYDUS Nitrile ExaminationGloves, Powder Free is adisposable deviceintended for medical purposesthat is worn on the examiner'shand or fingers to preventcontamination between patientand examiner. | Same |
| Materials of Use(ASTMD6910/D6910M-19) | Nitrile compound | Nitrile compound | Same |
| Color | Blue | Blue | Same |
| Texture | Finger Textured | Finger Textured | Same |
| Size(ASTM D6319-19) | Small, Medium, Large,Extra Large | Small, Medium, Large,Extra Large | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | Same |
| Dimensions(ASTM D6319-19) | Length Min. 230 min Width Min95+/-10 mm (for medium size) | Length Min. 230 min WidthMin 95+/-10 mm (for mediumsize) | Same |
| Physical Properties(ASTM D6319-19) | Before AgingTensile StrengthMin 14 Mpa Ultimate ElongationMin 500%After AgingTensile StrengthMin 14 Mpa Ultimate ElongationMin 400% | Before AgingTensile StrengthMin 14 Mpa UltimateElongation Min 500%After AgingTensile StrengthMin 14 Mpa UltimateElongation Min 400% | Same |
| Thickness(ASTM D6319-19) | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same |
| Powder Free(ASTM D6319-19) | <2 mg/glove | <2 mg/glove | Same |
| Freedom from Holes(Water Tight -1000 ml) -ASTM D6319-19 (CrossReference D5151) | Passed | Passed | Same |
| Biocompatibility -SKIN SENSITIZATION -ISO 10993-10: 2010 (E) | Under the conditions of study notan irritant | Under the conditions of studynot an irritant | Same |
| Biocompatibility -SKIN IRRITATION - ISO10993-10: 2010 (E) | Under the conditions ofthe study not a sensitizer | Under the conditions ofthe study not asensitizer | Same |
| Biocompatibility - INVITRO CYTOTOXICITY- ISO10993-5: 2009(E) | Under the condition of the study,the test article showed nocytotoxicity to L-929 cells andcytotoxic level was 0. | Exhibit cytotoxicreactivity at 100%extract concentration(Grade 4 with neat extract).Non-cytotoxicreactivity at 50%, 25%,12.5% and 6.25%extract concentration. | Similar |
| Biocompatibility -ACUTE SYSTEMICTOXICITY - ISO 10993-11: 2017(E) | Under the conditions ofthe study no systemic toxicity | No systemic toxicityunder the experimentalconditions employed | Similar |
| Manufacturer(s) | Jiangsu Cherish MedicalTechnology Co., Ltd | Nathan Trading Co., Ltd |
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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19.
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7. NON-CLINICAL TESTING SUMMARY
PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASMT D6319-19Standard Specification forNitrile ExaminationGloves for MedicalApplication - PhysicalDimensions Test | To determine thewidth, length, andthickness of thegloves | Width: (for Small size)$80\pm10$ mm | Width: (for small size)82mm (Minimum)82 mm (Mean)85 mm (Maximum) |
| Length: (for Small size)220 mm (Minimum) | Length: (for small size)232 mm (Mean)230 mm (Minimum) | ||
| Thickness: (for Small size)Finger –0.05 mm (Minimum)Palm –0.05 mm (Minimum) | Thickness: (for small size)Finger –0.13 mm (Mean)0.12 mm (Minimum)Palm –0.08 mm (Mean)0.08 mm (Minimum) | ||
| Passed | |||
| Width: (for Medium size)$95\pm10$ mm | Width: (for medium size)91 mm (Minimum)92 mm (Mean)93 mm (Maximum) | ||
| Length: (for Medium size)230 mm (Minimum) | Length: (for medium size)242 mm (Mean)240 mm (Minimum) | ||
| Thickness: (for Medium size)Finger –0.05 mm (Minimum)Palm–0.05 mm (Minimum) | Thickness: (for medium size)Finger –0.14 mm (Mean)0.13 mm (Minimum)Palm –0.09 mm (Mean)0.08 mm (Minimum) | ||
| Passed | |||
| Width: (for Large size)$110\pm10$ mm | Width: (for large size)108 mm (Minimum)109 mm (Mean)110 mm (Maximum) | ||
| Length: (for large size)230 mm (Minimum) | Length: (for large size)239 mm (Mean)237 mm (Minimum) | ||
| Thickness: (for Large size)Finger–0.05 mm (Minimum)Palm0.05 mm (Minimum) | Thickness: (for large size)Finger –0.14 mm (Mean)0.13 mm (Minimum)Palm –0.09 mm (Mean)0.09 mm (Minimum) | ||
| Passed | |||
| ASMT D6319-19Standard Specification forNitrile ExaminationGloves for MedicalApplication - PhysicalDimensions Test | To determine thewidth, length, andthickness of thegloves | Width: (for Extra-large size)120±10 mmLength: (for Extra-large size)230 mm (Minimum)Thickness: (for Extra-large size)Finger -0.05 mm (Minimum)Palm -0.05 mm (Minimum) | Width: (for extra-large size)121 mm (Minimum)122 mm (Mean)125 mm (Maximum)Length: (for extra-large size)243 mm (Mean)240 mm (Minimum)Thickness: (for extra- large size)Finger -0.14 mm (Mean)0.13 mm (Minimum)Palm -0.09 mm (Mean)0.08 mm (Minimum)Passed |
| ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalRequirements Test | To determine thetensile strength andultimate elongationbefore and afteracceleration aging | Before Acceleration Aging:Tensile Strength (MPa):14 (Minimum)Ultimate Elongation (%):500 (Minimum)After Acceleration Aging:Tensile Strength (MPa):14 (Minimum)Ultimate Elongation (%):400 (Minimum) | Before Acceleration Aging:Tensile Strength (MPa):31 (Mean)17 (Minimum)Ultimate Elongation (%):563 (Mean)520 (Minimum)After Acceleration Aging:Tensile Strength (MPa):41 (Mean)28 (Minimum)Ultimate Elongation (%):555 (Mean)524 (Minimum)Passed |
| ASTM D6319-19(ASTM D5151-11)Standard Test Methodfor Detection of Holes inMedical Gloves | To determine theholes in the gloves | (Mean)AQL 2.5 | Passed |
| ASMT D6319-19(ASTM D6124-11)Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder inthe gloves | < 2.0 mg/glove | 1.02 mg/glove, Passed |
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BIO-COMPATIBILITY DATA
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ISO 10993-10 Biological evaluationof medical devices – Part 10: Testsfor skin irritation and skinsensitization | To determine the potential of thematerial under test to produce skinirritation in rabbits | Under thecondition ofstudy not anirritant | Under the condition ofstudy not an irritant |
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| ISO 10993-10 Biological evaluationof medical devices - Part 10: Testsfor skin irritation and skinsensitization | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inguinea pigs. | Under theconditions of thestudy not asensitizer. | Under the conditions ofthe study not a sensitizer. |
|---|---|---|---|
| ISO 10993-5 Biological evaluationof medical devices - Part 5: Testsfor in vitro cytotoxicity | To evaluate the in vitro cytotoxicpotential of the test item (bothinner and outer surface) Extractsin L-929 mouse fibroblasts cellsusing elution method | Under theconditions ofstudy noncytotoxic | Under the condition of thestudy, the test articleshowed no cytotoxicity toL-929 cells and cytotoxiclevel was 0. |
| ISO 10993-11:2017 Biologicalevaluation of medical devices–Part 11: Tests for acute systemictoxicity | The test item was evaluated foracute systemic toxicity in SwissAlbino Mice | Under theconditions of thestudy no systemictoxicity | Under the conditions ofthe study no systemictoxicity |
8. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves by the 510(k) process.
9. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the Disposable Medical Nitrile Examination Gloves Non sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate device K203191- LYDUS Nitrile Examination Gloves, Powder Free.
§ 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.