(96 days)
The Medical nitrile examination gloves (Model: SH001) 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, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface with textured fingertips and a rolled rim at the cuff edge. The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and performance data for "Medical nitrile examination gloves (Model: SH001)" to demonstrate substantial equivalence to a predicate device for FDA 510(k) clearance. This is a Class I medical device and the data provided is for non-clinical performance testing, primarily mechanical and biocompatibility tests, not an AI/Software-as-a-Medical-Device (SaMD) study.
Therefore, many of the requested items related to AI/SaMD studies (e.g., human-in-the-loop performance, expert ground truth, adjudication methods, multi-reader multi-case studies, training/test set sample sizes for AI, etc.) are not applicable to this submission focusing on physical product characteristics of examination gloves.
I will provide the information that is applicable from the provided text.
Acceptance Criteria and Device Performance for Medical Nitrile Examination Gloves (Model: SH001)
The device, Medical nitrile examination gloves (Model: SH001), underwent non-clinical performance testing to demonstrate its safety and effectiveness, primarily adhering to the ASTM D6319-19 standard. The study aimed to show substantial equivalence to a predicate device (K203593).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Standard) | Test Purpose | Acceptance Criteria | Reported Device Performance (Test Results) | Conclusion |
|---|---|---|---|---|
| ASTM D6319-19 - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width:S: 80±10 mmM: 95±10 mmL: 110±10 mmXL: 120±10 mmLength:S: ≥220 mmM/L/XL: ≥230 mm | Lot Batch 20210723C1:Width: S: 79-84mm, M: 93-97mm, L: 104-107mm, XL: 112-115mmLength: S: 231-235mm, M: 234-238mm, L: 237-240mm, XL: 238-243mmLot Batch 20210719A1:Width: S: 80-83mm, M: 93-96mm, L: 104-107mm, XL: 112-116mmLength: S: 231-235mm, M: 235-238mm, L: 237-240mm, XL: 239-243mmLot Batch 20210726A0:Width: S: 79-83mm, M: 94-97mm, L: 104-107mm, XL: 112-116mmLength: S: 232-235mm, M: 235-238mm, L: 237-240mm, XL: 238-243mm | Passed (for all 3 lots) |
| ASTM D6319-19 - Thickness Test | To determine the thickness of the gloves | Finger: ≥0.05mmPalm: ≥0.05mm | For all three lots (S/M/L/XL): Finger min: 0.13mm, Palm min: 0.13mm | Passed (for all 3 lots) |
| ASTM D6319-19 - Physical Properties (Tensile Strength & Ultimate Elongation) | To determine tensile strength and ultimate elongation before and after accelerated 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 (for all 3 lots) |
| ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes (Water Tight) | To determine the holes in the gloves | AQL 2.5 | For all three lots: Pass at AQL 2.5 | Passed (for all 3 lots) |
| ASTM D6319-19 (ASTM D6124-11) - Residual Powder | To determine the residual powder in the gloves | < 2.0 mg/glove | Lot Batch 20210723C1: 0.17 mg/gloveLot Batch 20210719A1: 0.23 mg/gloveLot Batch 20210726A0: 0.18 mg/glove | Passed (for all 3 lots) |
| ISO 10993-10 - Skin Irritation | To evaluate potential intracutaneous reactivity | Under the conditions of the study not an irritant | Under the conditions of study not an irritant | Passed |
| ISO 10993-10 - Skin Sensitization | To determine skin sensitization potential | Under the conditions of study not a sensitizer | Under the conditions of the study not a sensitizer | Passed |
| ISO 10993-11:2017 - Acute Systemic Toxicity | To evaluate for acute systemic toxicity | 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 and Data Provenance for the Test Set
- Sample Size: The document refers to "Lot Batch of 20210723C1," "Lot Batch of 20210719A1," and "Lot Batch of 20210726A0" for physical dimensions, tensile strength, elongation, freedom from holes, and residual powder tests. While specific numbers of gloves per batch are not provided in this summary, the testing was done on multiple production lots.
- Data Provenance: The manufacturing company, Jiangxi SanHao Medical Instruments Co.,Ltd, is located in China. The testing data would originate from their internal testing or qualified third-party labs, likely within China, as part of their manufacturing and quality control process. The nature of the testing is retrospective from manufactured batches to demonstrate compliance.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable: This is not an AI/SaMD study requiring expert interpretation of medical images or data. Ground truth for physical properties (e.g., dimensions, tensile strength) is established by standardized measurement methods according to ASTM and ISO standards, using calibrated equipment and trained technicians.
4. Adjudication Method for the Test Set
- Not Applicable: As this involves physical and chemical property testing of gloves, adjudication methods typically used for expert disagreement in medical image interpretation are not relevant. Test results are objective measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable: This is not an AI/SaMD study. No human readers or AI assistance for diagnostic tasks are involved.
6. Standalone Performance (AI algorithm only without human-in-the-loop performance)
- Not Applicable: This is not an AI/SaMD device. The "device" is a physical medical glove. The performance presented is "standalone" in the sense that it is the performance of the physical product itself under various specified tests, without human decision-making assistance beyond standard testing procedures.
7. Type of Ground Truth Used
- Objective Measurements against Standard Specifications: The ground truth for the device's performance is established by objective measurements (e.g., length in mm, tensile strength in MPa, powder content in mg/glove) that are compared against predefined numerical acceptance criteria specified in recognized industry standards (ASTM D6319-19, ASTM D5151-11, ASTM D6124-11, ISO 10993-10, ISO 10993-11). For biocompatibility, the ground truth is the biological response (e.g., "not an irritant," "not a sensitizer," "no systemic toxicity") observed in animal models, as per ISO standards.
8. Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of device performance testing for a physical product like examination gloves. The manufacturing process is designed to consistently produce gloves meeting the specifications, and the tests are for verification/validation, not for training a model.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for a physical product, this question is not relevant.
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February 19, 2022
Jiangxi SanHao Medical Instruments Co.,Ltd % Cassie Lee Manger Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District, Guangzhou, Guangdong China
Re: K213600
Trade/Device Name: Medical nitrile examination gloves (Model: SH001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 21, 2022 Received: January 24, 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,
Clarence W. Murray III -S
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) K213600
Device Name
Medical nitrile examination gloves (Model: SH001)
Indications for Use (Describe)
The Medical nitrile examination gloves (Model: SH001) 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 of K213600
This summary of 510(k) is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: January 29, 2022
2. Submitter's Information
Sponsor Name: Jiangxi SanHao Medical Instruments Co.,Ltd Address: Chengxi Industrial Park, Jishui County, Ji'an City, Jiangxi Province. China Post Code: 331699 Contact name: Wanqfenfanq (General Manager) Tel: +86 0796-3256750 Phone: +86-151 7966 0192 E-mail: 1218060588@qq.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: SH001 Review Panel: General Hospital Product Code: LZA Requlation Number: 21 CFR 880.6250 Regulatory Class: Class I
4. Predicate Device Information
Sponsor: Guang Dong Kingfa SCI. & TECH.CO., LTD.
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Common Name: Polymer Patient Examination Glove 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, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface with textured fingertips and a rolled rim at the cuff edge. The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
6. Intended Use / Indications for Use
The Medical nitrile examination gloves (Model: SH001) is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powderfree, non-sterile device.
| Elements ofComparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| Company | Jiangxi SanHao MedicalInstruments Co.,Ltd | Guang Dong Kingfa SCI. &TECH.CO., LTD. | -- |
| 510 (k) Number | K213600 | 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 (Model: SH001) is intendedto be worn on | The nitrile examination glove isintended to be worn on the hands | Similar |
| Elements ofComparison | Subject Device | Predicate Device | Result |
| the hands of examiners to preventcontamination between patient andexaminer. This is a single-use,powder-free, non-sterile device. | of examiners to preventcontamination between patientand examiner. This is a single-use, powder-free, non-steriledevice. | ||
| Material of Use | Nitrile rubber | Nitrile rubber | Same |
| Color | Blue | Blue | Same |
| Texture | Finger Textured | Finger Textured | Same |
| 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 widthSmall (80±10mm)Medium (95±10mm)Large (110±10mm)X large (120±10mm) | ||
| Physical Properties(ASTM D6319-19) | Meets requirements of the ASTMD6319-19 | Meets requirements of the ASTMD6319-19 | Same |
| After Aging:Tensile Strength: ≥14MpaUltimate Elongation: ≥400% | After Aging:Tensile Strength: Min 14MpaUltimate Elongation: 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 | |
| Elements ofComparison | Subject Device | Predicate Device | Result |
| Powder Free(ASTM D6319-19) | ≤2 mg/glove | ≤2 mg/glove | Same |
| Freedom from Holes(Water Tight -1000ml)-ASTM D6319-19(Cross ReferenceD5151) | 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 |
7. Comparison to predicate device and conclusion
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8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
Performance Testing Summary: 1)
| Test Method | Test Purpose | AcceptanceCriteria | Test Results | Conclusion |
|---|---|---|---|---|
| ASMT D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication -PhysicalDimensions Test | To determine thewidth, length,and thickness ofthe gloves | Width:For S: $80\pm10$ mmFor M: $95\pm10$ mmFor L: $110\pm10$ mmFor XL: $120\pm10$ mmLength:For S: $\geq220$ mmFor M: $\geq230$ mmFor L: $\geq230$ mmFor XL: $\geq230$ mm | Lot Batch of20210723C1:Width:For S: 79 | Passed |
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| For L: 237 | ||
|---|---|---|
| Lot Batch of20210719A1:Width:For S: 80 | ||
| Lot Batch of20210726A0:Width:For S: 79 | ||
| Thickness:Finger: ≥0.05mmPalm: ≥0.05mm | For all three lots:For S/M/L/XL:Finger min: 0.13mm |
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| ASMT D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication -PhysicalDimensions Test | To determine thetensile strengthand ultimateelongationbefore and afteraccelerationaging | Before Aging:Tensile Strength:$\geq$ 14MpaUltimate Elongation:$\geq$ 500%After Aging:Tensile Strength:$\geq$ 14MpaUltimate Elongation:$\geq$ 400% | For all three lots:Before Aging:Tensile Strength:$\geq$ 14MpaUltimate Elongation:$\geq$ 500%After Aging:Tensile Strength:$\geq$ 14Mpa UltimateElongation: $\geq$ 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 of20210723C1:For S/M/L/XL: Pass at0.17 mg/gloveLot Batch of20210719A1:For S/M/L/XL: Pass at0.23 mg/gloveLot Batch of20210726A0:For S/M/L/XL: Pass at0.18 mg/glove | Passed |
2) Biocompatibility Testing Summary:
| Test Method | Test Purpose | Acceptance Criteria | Test Results | Conclusion |
|---|---|---|---|---|
| ------------- | -------------- | --------------------- | -------------- | ------------ |
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| 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 thestudy not anirritant | Under theconditions ofstudy not anirritant | Passed |
|---|---|---|---|---|
| ISO 10993-10Biological evaluationof medical devices -Part 10: Tests for skinirritation and skinsensitization | To determine the skinsensitization potentialin guinea pigs. | Under theconditions of studynot a sensitizer | Under theconditions of thestudy not asensitizer | 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.
9. Final Conclusion:
The conclusions drawn from the non-clinical testing demonstrate that the Medical nitrile examination gloves (Model: SH001) are as safe, as effective, and perform as well as or better than the legally marketed predicate (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.