(105 days)
The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.
Here's a breakdown of the acceptance criteria and the study information for the Medical Nitrile Examination Gloves (Model: JL001), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Test Purpose | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| ASTM D6319-19 (Physical Dimensions) | To determine the width, length, and thickness of the gloves | Width:For S: 80±10 mmFor M: 95±10 mmFor L: 110±10 mmFor XL: 120±10 mmLength:For S: ≥220mmFor M/L/XL: ≥230mmFinger Thickness: min. 0.05 mmPalm Thickness: min. 0.05 mm | Lot Batch 20210716A:Width: S: 79 | Passed |
| ASTM D6319-19 (Physical Properties) | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Aging:Tensile Strength: ≥14MpaUltimate Elongation: ≥500%After Aging:Tensile Strength: ≥14MpaUltimate Elongation: ≥400% | For all three lots:Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500%After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Passed |
| ASTM D6319-19 (ASTM D5151-11) (Freedom from Holes) | To determine the holes in the gloves | AQL 2.5 | For all three lots: Pass at AQL 2.5 | Passed |
| ASTM D6319-19 (ASTM D6124-11) (Residual Powder) | To determine the residual powder in the gloves | < 2.0 mg/glove | Lot Batch 20210716A: 0.12 mg/gloveLot Batch 20210719A: 0.15 mg/gloveLot Batch 20210721C: 0.21 mg/glove | Passed |
| ISO 10993-10 (Skin Irritation) | To evaluate the potential intracutaneous reactivity caused by intracutaneously inject the extract to rabbits | Under the conditions of study not an irritation | Under the conditions of study not an irritation | Passed |
| ISO 10993-10 (Skin Sensitization) | To determine the skin sensitization potential in guinea pigs | Under the conditions of the study not a sensitization | Under the conditions of the study not a sensitization | Passed |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | The test item was evaluated for acute systemic toxicity in ICR mouse | Under the conditions of the study no systemic toxicity | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document provides information on three lot batches used for non-clinical performance testing:
- Lot Batch: 20210716A
- Lot Batch: 20210719A
- Lot Batch: 20210721C
The specific number of gloves sampled from each lot for each test (e.g., number of gloves for width/length, number of gloves for tensile strength, number of gloves for freedom from holes test to meet AQL 2.5) is not explicitly stated in the provided text. The data provenance is industrial testing of manufacturer's product, consistent with regulatory submissions for medical devices. The country of origin of the data is not explicitly stated, but the manufacturer is Guangdong Jiali Pharmaceutical Co.,Ltd in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes non-clinical performance testing (physical, chemical, and biocompatibility tests) of a medical device (nitrile examination gloves), not a study involving expert interpretation or medical imaging analysis. The "ground truth" for these tests is established by standardized laboratory methods and measurements according to ASTM and ISO standards.
4. Adjudication Method for the Test Set
This is not applicable as the study involves standardized physical and biocompatibility testing with objective pass/fail criteria, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers evaluate cases with and without AI assistance. This document describes the performance of examination gloves, which is not a diagnostic device.
6. Standalone Performance Study
Yes, a standalone study was done. The document focuses on the performance of the "Medical nitrile examination gloves" (JL001) itself against established international standards (ASTM and ISO). The device's performance was evaluated independently without human-in-the-loop interaction in a diagnostic sense.
7. Type of Ground Truth Used
The ground truth used for the non-clinical performance tests is based on established international standards and objective measurements:
- For physical properties (width, length, thickness, tensile strength, elongation, residual powder, freedom from holes): Adherence to specific quantitative thresholds defined in ASTM D6319-19 and referenced standards like ASTM D5151-11 and ASTM D6124-11.
- For biocompatibility: The biological response (irritation, sensitization, systemic toxicity) observed in animal models, evaluated against criteria defined in ISO 10993-10 and ISO 10993-11:2017.
8. Sample Size for the Training Set
This information is not applicable. The device described is a physical medical device (examination gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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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.
March 25, 2022
Guangdong Jiali Pharmaceutical Co.,Ltd % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920. Building D3, Miniie Plaza, Shuixi Road, Huang District Guangzhou, Guangdong China
Re: K213848
Trade/Device Name: Medical nitrile examination gloves (Model: JL001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 14, 2022 Received: February 18, 2022
Dear Cassie Lee:
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.
Bifeng Qian, M.D., Ph.D. Acting 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) K213848
Device Name
Medical nitrile examination gloves (Model: JL001)
Indications for Use (Describe)
The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
| 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 K213848
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: March 15, 2022
2. Submitter's Information
Sponsor Name: Guangdong Jiali Pharmaceutical Co.,Ltd Address: Dawei, Niuqutian Villagers Committee, Muzhou Town, Xinhui, Jiangmen,Guangdong,China Post Code: 529143 Contact name: Jiali Chen Tel: +86-0750-3835982 Tel: +86-15988225228 E-mail: 275119024@gq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minije Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@share-info.com
3. Subject Device Information
Type of 510(k): Traditional Common Name: Polymer Patient Examination Glove Classification Name: Non-powdered patient examination glove Trade Name: Medical nitrile examination qloves Model Name: JL001 Review Panel: General Hospital Product Code: LZA Requlation Number: 21 CFR 880.6250 Requlatory Class: Class I
4. Predicate Device Information
Sponsor: Guang Dong Kingfa SCI. & TECH.CO., LTD. Common Name: Polymer Patient Examination Glove
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Classification Name: Non-Powdered Patient Examination Glove Trade Name: Patient Examination Gloves 510(k) Number: K203593 Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Regulatory Class: Class I
5. Device Description
The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.
6. Intended Use / Indications for Use
The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
| 7. Comparison to predicate device and conclusion | ||
|---|---|---|
| -------------------------------------------------- | -- | -- |
| Elements ofComparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| Company | Guangdong Jiali PharmaceuticalCo.,Ltd | Guang Dong Kingfa SCI. &TECH.CO., LTD. | -- |
| 510 (k) Number | K213848 | K203593 | -- |
| Trade Name | Medical nitrile examination gloves | Patient Examination Gloves | -- |
| Product Code | LZA | LZA | -- |
| Classification Name | Non-Powdered PatientExamination Glove | Non-Powdered PatientExamination Glove | Same |
| Classification | Class I | Class I | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications For Use | The Medical nitrile examinationgloves is intended to be worn onthe hands of examiners toprevent contamination betweenpatient and examiner. This is a | The nitrile examination glove isintended to be worn on the handsof examiners to preventcontamination between patientand examiner. This is a single- | Same |
| Elements ofComparison | Subject Device | Predicate Device | Result |
| single-use, powder-free, non-sterile device. | single-use, powder-free, non-sterile device. | ||
| Material of Use | Nitrile rubber | Nitrile rubber | Same |
| Color | Blue | Blue | Same |
| Texture | No | Finger Textured | DifferentNote |
| Size(ASTM D6319-19) | Small, Medium, Large, X Large | Small, Medium, Large, X Large | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | Same |
| Dimensions(ASTM D6319-19) | Length:For S: ≥220 mmFor M/L/XL: ≥230 mm | Length:S (220mm min)M (230mm min)L (230mm min)XL (230mm min) | Same |
| Width:For S: 80±10mmFor M: 95±10 mmFor L: 110±10 mmFor XL: 120±10 mm | Palm width:Small (80±10mm)Medium (95±10mm)Large (110±10mm)X large (120±10mm) | ||
| Physical Properties(ASTM D6319-19) | Meets requirements of the ASTMD6319-19Before Aging:Tensile Strength: ≥14MpaUltimate Elongation: ≥500% | Meets requirements of the ASTMD6319-19Before Aging:Tensile Strength: Min 14 MpaUltimate Elongation: Min 500% | Same |
| Meets requirements of the ASTMD6319-19After Aging:Tensile Strength: ≥14MpaUltimate Elongation: ≥400% | Meets requirements of the ASTMD6319-19After Aging:Tensile Strength: Min 14MpaUltimate Elongation: Min 400% | ||
| 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 |
| Elements ofComparison | Subject Device | Predicate Device | Result |
| Freedom from Holes(Water Tight -1000 ml)-ASTM D6319-19(Cross Reference D5151) | Meets requirements of the ASTMD6319-19 | Meets requirements of the ASTMD6319-19 | Same |
| Biocompatibility -Skin Sensitization(ISO 10993-10:2010) | Under the conditions of the studynot a sensitizer | Under the conditions of the studynot a sensitizer | Same |
| Biocompatibility -Skin Irritation (ISO10993-10:2010) | Under the conditions of study notan irritant | Under the conditions of study notan irritant | Same |
| Biocompatibility -Acute SystemicToxicity (ISO 10993-11: 2017) | Cytotoxicity is assessed viarationale. Under the condition ofacute systemic toxicity test,the test article did not show acutesystemic toxicity in vivo. | Cytotoxicity is assessed viarationale. Under the condition ofacute systemic toxicity test,the test article did not show acutesystemic toxicity in vivo. | Same |
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Comparison in Detail(s):
Note:
Although the subject device has no texture, which is different from the predicate device, both the performance of the subject device and predicate device met the requirements of the standard ASTM D6319-19. So, the difference between the subject device and predicate device will not affect the safety and effectiveness.
8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
1) Performance Testing Summary:
| Test Method | Test Purpose | AcceptanceCriteria | Test Results | Conclusion |
|---|---|---|---|---|
| ASMT D6319-19 | To determine the | Width: | Lot Batch of | Passed |
| Standard | width, length, | For S: $80\pm10$ mm | 20210716A: | |
| Specification for | and thickness of | For M: $95\pm10$ mm | Width: | |
| Nitrile Examination | the gloves | For L: $110\pm10$ mm | For S: 79~83mm | |
| Gloves for Medical | For XL: $120\pm10$ mm | For M: 93~97mm |
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| Application -PhysicalDimensions Test | Length:For S: ≥220mmFor M: ≥230mmFor L: ≥230mmFor XL: ≥230mm | For L: 101-105mmFor XL: 110mmLength:For S: 233 |
|---|---|---|
| ---------------------------------------------- | ------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Finger min: 0.12mmPalm min: 0.08mm | ||||
|---|---|---|---|---|
| Lot Batch of20210719A:For S/M/L/XL:Finger min: 0.13mmPalm min: 0.08mm | ||||
| Lot Batch of20210721C:For S/M/L/XL:Finger min: 0.13mmPalm min: 0.08mm | ||||
| ASMT D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication -PhysicalDimensions Test | To determine thetensile strengthand ultimateelongationbefore and afteraccelerationaging | Before Aging:Tensile Strength:≥14MpaUltimate Elongation:≥500%After Aging:Tensile Strength:≥14MpaUltimate Elongation:≥400% | For all three lots:Before Aging:Tensile Strength:≥14MpaUltimate Elongation:≥500%After Aging:Tensile Strength:≥14Mpa UltimateElongation: ≥400% | Passed |
| ASTM D6319-19(ASTM D5151-11)Standard TestMethod forDetection of Holesin Medical Gloves | To determine theholes in thegloves | AQL 2.5 | For all three lots:Pass at AQL 2.5 | Passed |
| ASMT D6319-19(ASTM D6124-11)Standard TestMethod forResidual Powderon Medical Gloves | To determine theresidual powderin the gloves | < 2.0 mg/glove | Lot Batch of20210716A:For S/M/L/XL: Pass at0.12 mg/gloveLot Batch of | Passed |
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| 20210719A:For S/M/L/XL: Pass at0.15 mg/gloveLot Batch of20210721C:For S/M/L/XL: Pass at0.21 mg/glove | ||
|---|---|---|
| -- | -- | ---------------------------------------------------------------------------------------------------------------------------------- |
2) Biocompatibility Testing Summary:
| Test Method | Test Purpose | AcceptanceCriteria | Test Results | Conclusion |
|---|---|---|---|---|
| ISO 10993-10Biological evaluationof medical devices -Part 10: Tests for skinirritation and skinsensitization | To evaluate thepotentialintracutaneousreactivity caused byintracutaneously injectthe extract to rabbits | Under theconditions of studynot an irritation | Under theconditions ofstudy not anirritation | Passed |
| ISO 10993-10Biological evaluationof medical devices -Part 10: Tests for skinirritation and skinsensitization | To determine the skinsensitization potentialin guinea pigs. | Under theconditions of thestudy not asensitization | Under theconditions of thestudy not asensitization | Passed |
| ISO 10993-11:2017Biological evaluationof medical devices -Part 11: Tests foracute systemic toxicity | The test item wasevaluated for acutesystemic toxicity inICR mouse | Under theconditions of thestudy no systemictoxicity | Under thecondition ofacute systemictoxicity test,the test articledid not showacute systemictoxicity in vivo. | Passed |
8.2 Summary of Clinical Performance Test
No clinical study is included in this submission.
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9. Final Conclusion:
The subject device is a safe, as effective, and perform as well as or better than the legally marketed predicated K203593.
§ 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.