(87 days)
Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves are made from nitrile butadiene rubber that covers the hand up to the wrist. They are cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. The device is available in four sizes, which are S, M, L, XL. It could be selected by the user depending on the size of hand. All sizes share the same blue color. The gloves are non-sterile, powder free and are for single use only.
The provided document is a 510(k) summary for Nitrile Examination Gloves (Model: ZMG1351). It details the device's characteristics, comparison to a predicate device, and results from non-clinical testing. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension - ASTM D6319-19 | Evaluate the glove palm width | S: 80±10mmM: 95±10mmL: 110±10mmXL: 120±10mm | S: 84 |
| Evaluate the glove length | S: Min 220mmM: Min 230mmL: Min 230mmXL: Min 230mm | S: 241 | |
| Evaluate the glove finger thickness | S, M, L, XL: Min 0.05mm | S: 0.111 | |
| Evaluate the glove palm thickness | S, M, L, XL: Min 0.05mm | S: 0.080 | |
| Physical Properties - ASTM D6319-19 | Evaluate the glove physical properties before and after aging | Before Aging:- Tensile Strength: Min 14Mpa- Ultimate Elongation: Min 500%After Aging:- Tensile Strength: Min 14Mpa- Ultimate Elongation: Min 400% | Before Aging:- Tensile Strength: 19.9 |
| Freedom from Holes - ASTM D6319-19 | Detect the holes that allow water leakage | Do not show droplet, stream, or other type of water leakage (Pass at AQL 2.5, as per comparison table) | Performance reported as meeting the acceptance criteria (based on the "Test Results" column not explicitly stating values but confirming compliance with acceptance criteria for all tests) |
| Powder Residue - ASTM D6319-19 | Evaluate the residue powder | ≤2mg/glove | Performance reported as meeting the acceptance criteria (based on the "Test Results" column not explicitly stating values but confirming compliance with acceptance criteria for all tests) |
| Skin Irritation - ISO 10993-10:2010 | Evaluated for the potential to cause skin irritation | Under the condition of the test, not an irritant. | Performance reported as meeting the acceptance criteria (based on the "Test Results" column not explicitly stating values but confirming compliance with acceptance criteria for all tests) |
| Sensitization - ISO 10993-10:2010 | Evaluated for the potential to cause skin sensitization | Under the condition of the test, not a sensitizer. | No-sensitization (Performance reported as meeting the acceptance criteria as per "No- sensitization" in "Test Results" column and confirmation of compliance for all tests) |
| Acute Systemic Toxicity - ISO 10993-11:2017 | Evaluated for acute systemic toxicity | Under the condition of the test, not a systemic toxicity. | No-acute systemic toxicity (Performance reported as meeting the acceptance criteria as per "No- acute systemic toxicity" in "Test Results" column and confirmation of compliance for all tests) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each test. It simply states that "Bench tests were conducted to verify that the proposed device met all design specifications." The data provenance is not explicitly mentioned, but given the manufacturer (Wuhan Zonsen Medical Products Co.,Ltd) and contactor (Shanghai CV Technology Co., Ltd.) locations, it is highly likely the testing and data originated from China. The study appears to be retrospective in the sense that these are design verification tests performed on manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the document describes physical and biocompatibility testing of medical gloves, not an AI or diagnostic device that requires expert interpretation to establish a ground truth. The "ground truth" for these tests is based on established international standards (ASTM and ISO).
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as above. The tests performed are objective measurements against predefined criteria in established 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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for basic medical devices like examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical product (nitrile examination gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the acceptance criteria and testing of the Nitrile Examination Gloves is based on established industry standards and protocols:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
- ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
The tests measure physical properties and biological responses against scientifically defined and accepted limits.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI or machine learning device. The tests are for product verification and validation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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February 18, 2022
Wuhan Zonsen Medical Products Co.,Ltd % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K213688
Trade/Device Name: Nitrile Examination Gloves (Model: ZMG1351) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 10, 2021 Received: November 23, 2021
Dear Doris Dong:
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.
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) K213688
Device Name
Nitrile Examination Gloves (Model: ZMG1351)
Indications for Use (Describe)
Nitrile Examination Gloves are disposable devices intended for medical purposes that are 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 required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K213688 |
|---|---|
| Date: | February 3rd, 2022 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Wuhan Zonsen Medical Products Co.,LtdNo 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City,Hubei Province, ChinaTel: +86-27-82737771E-mail: Cynthia@zonsenmed.com |
| Contactor: | Doris DongShanghai CV Technology Co., Ltd.Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 ChinaE-mail: doris.d@ceve.org.cnTel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description
| Proprietary Name: | Nitrile Examination Gloves |
|---|---|
| Model: | ZMG1351 |
| Size: | S, M, L, XL |
| Classification Name: | Non-powdered patient examination glove |
| Product Code: | LZA |
| Device Class: | 1 |
| Regulation Number: | 21 CFR 880.6250 |
| Review Panel: | General Hospital |
| Indications for use: | Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. |
| Device Description: | Nitrile Examination Gloves are made from nitrile butadiene rubber that covers the hand up to the wrist. They are cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. The device is available in four sizes, which are S, M, L, XL. It could be selected by the user depending on the size of hand. All sizes share the same blue color. The gloves are non-sterile, powder free and are for single use only. |
3. Predicate Device Identification
| 510(k) Number: | K211319 |
|---|---|
| Product Name: | Purism Non-Sterile Powder Free Nitrile Examination Gloves |
| Submitter/Manufacturer: | Dezhou Purism Medical Technology Co., Ltd. |
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4. Technological Characteristics Comparison
| Parameters | New Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) Number | K213688 | K211319 | --- |
| 510(k) Owner | Wuhan Zonsen Medical ProductsCo.,Ltd | Dezhou Purism MedicalTechnology Co., Ltd. | --- |
| Device Name | Nitrile Examination Gloves | Purism Non-Sterile Powder FreeNitrile Examination Gloves | --- |
| Model | ZMG1351 | / | --- |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | 1 | 1 | Same |
| Intended use | Nitrile Examination Gloves aredisposable devices intended formedical purposes that are wornon the examiner's hand to preventcontamination between patientand examiner. | The Purism Non-Sterile PowderFree Nitrile Examination Glovesis disposable devices intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner. | Same |
| Material | Nitrile Butadiene Rubber Latex | Nitrile Butadiene Rubber Latex | Same |
| Environment ofuse | OTC | OTC | Same |
| Design | Disposable (Single use) | Disposable (Single use) | Same |
| Non-sterile | Non-sterile | Same | |
| Powder-free | Powder-free | Same | |
| Ambidextrous | Ambidextrous | Same | |
| Cuffed | Cuffed | Same | |
| Size | S, M, L, XL | S, M, L, XL | Same |
| Color | Blue | Blue | Same |
| Specifications | Powder-free Nitrile ExaminationGloves Meet ASTM D6319-19 | Powder-free Nitrile ExaminationGloves Meet ASTM D6319-19 | Same |
| Dimensions- Overall Length | Meets ASTM D6319-19S: Min 220mmM: Min 230mmL: Min 230mmXL: Min 230mm | Meets ASTM D6319-19S: Min 230mmM: Min 230mmL: Min 230mmXL: Min 230mm | Similar |
| Dimensions- Palm Width | Meets ASTM D6319-19S: 80±10mmM: 95±10mmL: 110±10mmXL: 120±10mm | Meets ASTM D6319-19S: 80±10mmM: 95±10mmL: 110±10mmXL: ≥110mm | |
| Dimensions- Finger Thickness | Meets ASTM D6319-19Min 0.05mm | Meets ASTM D6319-19Min 0.10±0.02mm | |
| Dimensions- Palm Thickness | Meets ASTM D6319-19Min 0.05mm | Meets ASTM D6319-19Min 0.06±0.02mm |
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| Physical Properties | Meets ASTM D6319-19Before Aging:- Tensile Strength: min 14Mpa- Ultimate Elongation: min 500%Meets ASTM D6319-19After aging:- Tensile Strength: min 14Mpa- Ultimate Elongation: min 400% | Meets ASTM D6319-19Before Aging:- Tensile Strength: min 14Mpa- Ultimate Elongation: min 500%Meets ASTM D6319-19After aging:- Tensile Strength: min 14Mpa- Ultimate Elongation: min 400% | Same |
|---|---|---|---|
| Freedom fromHoles | Meets ASTM D6319-19Pass at AQL 2.5 | ASTM D5151-06Pass at AQL 2.5 | Similar |
| Powder residue | Meets ASTM D6319-19Below 2mg/glove of residualpowder | Meets ASTM D6124-06Below 2mg/glove of residualpowder | |
| Biocompatibility | Meets ISO 10993-10:2010;Skin Irritation: Under thecondition of the test, not anirritant.Skin Sensitization: Under thecondition of the test, not asensitizer.Meets ISO 10993-11:2017;Acute Systemic Toxicity: Underthe condition of the test, not asystemic toxicity. | Meets ISO 10993-10:2010;Skin Irritation: Under thecondition of the test, not anirritant.Skin Sensitization: Under thecondition of the test, not asensitizer.Meets ISO 10993-11:2017;Acute Systemic Toxicity: Underthe condition of the test, not asystemic toxicity.Meets ISO 10993-5:2009;In Vitro Cytotoxicity: Under thecondition of the test, cytotoxic | Similar |
5. Non-clinical Testing Summary
Bench 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:
-
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
-
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
-
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
| Test Method | Purpose | Acceptance Criteria | Test Results | ||
|---|---|---|---|---|---|
| Dimension-ASTM D6319-19 | Evaluate theglove palm width | Size | (mm) | (mm) | |
| S | $80\pm10$ | 84~86 | |||
| M | $95\pm10$ | 96~98 | |||
| L | $110\pm10$ | 104~106 | |||
| XL | $120\pm10$ | 113~115 | |||
| Evaluate the | Size | (mm) | (mm) | ||
| glove length | S | Min 220 | 241~251 | ||
| M | Min 230 | 236~249 | |||
| L | Min 230 | 237~245 | |||
| XL | Min 230 | 240~249 | |||
| Evaluate theglove fingerthickness | Size | (mm) | (mm) | ||
| S | Min 0.05 | 0.111~0.137 | |||
| M | Min 0.05 | 0.124~0.150 | |||
| L | Min 0.05 | 0.112~0.133 | |||
| XL | Min 0.05 | 0.117~0.137 | |||
| Evaluate theglove palmthickness | Size | (mm) | (mm) | ||
| S | Min 0.05 | 0.080~0.097 | |||
| M | Min 0.05 | 0.087~0.098 | |||
| L | Min 0.05 | 0.074~0.086 | |||
| XL | Min 0.05 | 0.077~0.094 | |||
| Physical Properties-ASTM D6319-19 | Evaluate theglove physicalpropertiesbeforeand after aging | BeforeAging | After aging | Before Aging | After aging at |
| Tensilestrength: | Tensilestrength: | Tensilestrength: | Tensilestrength: | ||
| min 14Mpa | min 14Mpa | 19.9~27.4Mpa | 20.1~35.1Mpa | ||
| Ultimateelongation: | Ultimateelongation: | Ultimateelongation: | Ultimateelongation: | ||
| min 500% | min 400% | 509~553% | 454~504% | ||
| Freedom fromHoles-ASTM D6319-19 | Detect the holesthat allow waterleakage | Do not show droplet, stream or other type ofwater leakage | |||
| Powder residue-ASTM D6319-19 | Evaluate theresidue powder | ≤2mg/glove | |||
| Skin Irritation -ISO 10993-10:2010 | Evaluated for thepotential to causeskin irritation | ||||
| Sensitization -ISO 10993-10:2010 | Evaluated for thepotential to causeskin sensitization | Under the condition of thetest, not a sensitizer. | No- sensitization | ||
| Acute SystemicToxicity-ISO 10993-11:2017 | Evaluated foracute systemictoxicity | Under the condition of thetest, not a systemictoxicity. | No- acute systemic toxicity |
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6. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, the Nitrile Examination Gloves, are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K211319.
§ 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.