(89 days)
The Disposable Medical Nitrile gloves 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 proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are composed of Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and blue colorant Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface 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 document provided is a 510(k) summary for Disposable Medical Nitrile gloves (K213851) and thus describes non-clinical performance testing rather than a study for an AI-powered device. Therefore, many of the requested categories are not applicable.
Here's the information that can be extracted from the provided text, focused on the acceptance criteria and the tests performed for the Disposable Medical Nitrile gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference Standard) | Acceptance Criteria | Reported Device Performance (All three lots: 20210825B, 20210827A, 20210830A) | Conclusion |
|---|---|---|---|
| ASMT D6319-19 - Physical Dimensions (Width) | S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | S: 83-86mm (Lot B), 83-85mm (Lot A), 83-85mm (Lot A); M: 91-92mm (Lot B), 91-93mm (Lot A), 90-92mm (Lot A); L: 104-106mm (Lot B), 104-106mm (Lot A), 104-106mm (Lot A); XL: 112-114mm (Lot B), 111-113mm (Lot A), 112-115mm (Lot A) | Passed |
| ASMT D6319-19 - Physical Dimensions (Length) | S: ≥220 mm; M/L/XL: ≥230 mm | S: 234-236mm; M: 235-237mm; L: 237-239mm (Lot B,A), 237-240mm (Lot A); XL: 237-239mm | Passed |
| ASMT D6319-19 - Physical Dimensions (Thickness) | Finger: ≥0.05mm; Palm: ≥0.05mm | Finger: S/M: Pass at 0.11mm (Lot B, A), S/M/L: Pass at 0.11mm (Lot A), L/XL: Pass at 0.12mm (Lot B), M/L/XL: Pass at 0.12mm (Lot A), XL: Pass at 0.12mm (Lot A); Palm: S/M/L/XL: Pass at 0.08mm | Passed |
| ASMT D6319-19 - Physical Properties (Before Aging) | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥500% | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥500% | Passed |
| ASMT D6319-19 - Physical Properties (After Aging) | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥400% | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥400% | Passed |
| ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes | AQL 2.5 | Pass at AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) - Residual Powder | < 2.0 mg/glove | Lot 20210825B: Pass at 0.22 mg/glove; Lot 20210827A: Pass at 0.19 mg/glove; Lot 20210830A: Pass at 0.20 mg/glove | Passed |
| ISO 10993-10 - Skin Irritation | Under the conditions of study not an irritation | Under the conditions of study not an irritation | Passed |
| ISO 10993-10 - Skin Sensitization | 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 | 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 refers to "three lots" (Lot 20210825B, Lot 20210827A, Lot 20210830A) for the performance testing. However, the specific sample sizes (number of gloves) tested within each lot for each test are not explicitly stated in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified for these tests. This is a non-clinical device (gloves), so data provenance details like for AI/software would not typically apply.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is Disposable Medical Nitrile gloves, not an AI or diagnostic imaging device that requires expert ground truth establishment. The performance is based on physical and biological property testing against recognized standards.
4. Adjudication Method
This information is not applicable for the type of product and testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement
This information is not applicable as the device is Disposable Medical Nitrile gloves, not an AI or diagnostic imaging device. No MRMC study was mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This information is not applicable as the device is Disposable Medical Nitrile gloves, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by conformance to recognized international standards such as ASMT D6319-19, ASTM D5151-11, ASTM D6124-11, ISO 10993-10, and ISO 10993-11:2017. These standards define the acceptable physical dimensions, tensile strength, elongation, freedom from holes, residual powder, and biocompatibility (skin irritation, sensitization, acute systemic toxicity).
8. The Sample Size for the Training Set
This information is not applicable as the device is Disposable Medical Nitrile gloves and does not involve AI or machine learning models that require training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (no training set for this type of device).
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March 9, 2022
Guangdong Xingcan Brothers Medical Technology Co.,Ltd % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3. Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong China
Re: K213851
Trade/Device Name: Disposable Medical Nitrile gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 6, 2021 Received: December 10, 2021
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.
For Clarence W. Murray, III, Ph.D. 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) K213851
Device Name Disposable Medical Nitrile gloves
Indications for Use (Describe)
The Disposable Medical Nitrile gloves 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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K213851 510(k) Summary
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: December 6, 2021
2. Submitter's Information
Sponsor Name: Guangdong Xingcan Brothers Medical Technology Co.,Ltd Address: Room B10, 4th Floor, No. 137 (plant A1), Pacific Industrial Zone, Xintang Town, Zengcheng District, Guangzhou Establishment Registration Number: Applying Post Code: 511300 Contact name: Suhai Yin Phone: +86 139 2426 4846 Fax: +86 755-8654 6919 E-mail: 1273722763@qq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: requlatory@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: Disposable Medical Nitrile gloves Specifications: Small (S), Medium (M), Large (L), X-large (XL) Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Regulatory Class: Class I
4. Predicate Device Information
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Sponsor: Guang Dong Kingfa SCI. & TECH.CO., LTD. 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 proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are composed of Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and blue colorant Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface 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 Disposable Medical Nitrile gloves 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.
| Elements of | Subject Device | Predicate Device | Result |
|---|---|---|---|
| Comparison | |||
| Company | Guangdong Xingcan Brothers MedicalTechnology Co.,Ltd | Guang Dong Kingfa SCI. &TECH.CO., LTD. | -- |
| 510 (k) Number | K213851 | K203593 | -- |
| Trade Name | Disposable Medical Nitrile gloves | Patient Examination Gloves | -- |
| Product Code | LZA | LZA | Same |
| ClassificationName | Non-Powdered Patient ExaminationGlove | Non-Powdered PatientExamination Glove | Same |
| Classification | Class I | Class I | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Elements ofComparison | Subject Device | Predicate Device | Result |
| Indications ForUse | The Disposable Medical Nitrile glovesintended to be worn on the hands ofexaminers to prevent contaminationbetween patient and examiner. This is asingle-use, powder-free, non-steriledevice. | The nitrile examination gloveis intended to be worn on thehands of examiners toprevent contaminationbetween patient andexaminer. This is a single-use, powder-free, non-steriledevice. | Same |
| Material of Use | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Size(ASTM D6319-19) | Small, Medium, Large, X Large | Small, Medium, Large, XLarge | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | Same |
| Dimensions(ASTM D6319-19) | Length:For S: $\ge$ 220 mmFor M/L/XL: $\ge$ 230 mm | Length:S (220mm min)M (230mm min)L (230mm min)XL (230mm min)Palm widthSmall (80±10mm)Medium (95±10mm)Large (110±10mm)X large (120±10mm) | Same |
| PhysicalProperties(ASTM D6319-19) | Meets requirements of the ASTM D6319-19Before Aging:Tensile Strength: $\ge$ 14MpaUltimate Elongation: $\ge$ 500%Meets requirements of the ASTM D6319-19After Aging: | Meets requirements of theASTM D6319-19Before Aging:Tensile Strength: Min 14 MpaUltimate Elongation: Min500%Meets requirements of theASTM D6319-19After Aging: | Same |
| Elements ofComparison | Subject Device | Predicate Device | Result |
| Tensile Strength: ≥14MpaUltimate Elongation: ≥400% | 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 |
| Freedom fromHoles (WaterTight -1000 ml)-ASTM D6319-19(CrossReferenceD5151) | Meets requirements of the ASTM D6319-19 | Meets requirements of the ASTM D6319-19 | Same |
| Biocompatibility– SkinSensitization(ISO 10993-10:2010) | Under the conditions of the study not asensitizer | Under the conditions of thestudy not a sensitizer | Same |
| Biocompatibility– Skin Irritation(ISO 10993-10:2010) | Under the conditions of study not anirritant | Under the conditions of studynot an irritant | Same |
| Biocompatibility– AcuteSystemicToxicity (ISO10993- 11:2017) | Cytotoxicity is assessed via rationale.Under the condition of acute systemictoxicity test,the test article did not show acutesystemic toxicity in vivo. | Cytotoxicity is assessed viarationale. Under the conditionof acute systemic toxicitytest,the test article did not showacute systemic toxicity invivo. | Same |
7. Technological Characteristics Comparison
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8. Test Summary
2.1 Summary of Non-Clinical Performance Testing
1) Performance Testing Summary:
| Test Method | Test Purpose | Acceptance Criteria | Test Results | Conclusion |
|---|---|---|---|---|
| ASMT D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication -PhysicalDimensions Test | To determinethe width,length, andthickness of thegloves | Width:For S: $80\pm10$ mmFor M: $95\pm10$ mmFor L: $110\pm10$ mmFor XL: $120\pm10$ mmLength:For S: $\ge220$ mmFor M: $\ge230$ mmFor L: $\ge230$ mmFor XL: $\ge230$ mm | For Lot 20210825B:Width:For S: 83 | Passed |
| For Lot 20210827A:Width:For S: 83-85mmFor M: 91 | ||||
| For Lot 20210830A:Width:For S: 83-85mmFor M: 90 |
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| For M: 235 | ||
|---|---|---|
| Thickness:Finger: ≥0.05mmPalm: ≥0.05mm | For Lot 20210825B:Finger:For S/M: Pass at0.11mmFor L/XL: Pass at0.12mmPalm:For S/M/L/XL: Passat 0.08mm | |
| For Lot 20210827A:Finger:For S: Pass at0.11mmFor M/L/XL: Pass at0.12mmPalm:For S/M/L/XL: Passat 0.08mm | ||
| For Lot 20210830A:For S/M/L: Pass at0.11mmFor XL: Pass at0.12mmPalm:For S/M/L/XL: Passat 0.08mm |
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| ASMT D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication –PhysicalDimensions Test | To determinethe tensilestrength andultimateelongationbefore and afteraccelerationaging | Before Aging:Tensile Strength:$≥14Mpa$UltimateElongation: $≥500%$After Aging:Tensile Strength:$≥14Mpa$UltimateElongation: $≥400%$ | For all three lots:Before Aging:Tensile Strength:$≥14Mpa$Ultimate Elongation:$≥500%$After Aging:Tensile Strength:$≥14Mpa$ UltimateElongation: $≥400%$ | Passed |
|---|---|---|---|---|
| ASTM D6319-19(ASTM D5151-11)Standard TestMethod forDetection of Holesin Medical Gloves | To determinethe holes 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 determinethe residualpowder in thegloves | < 2.0 mg/glove | For Lot 20210825B:For S/M/L/XL: Passat 0.22 mg/gloveFor Lot 20210827A:For S/M/L/XL: Passat 0.19 mg/gloveFor Lot 20210830A:For S/M/L/XL: Passat 0.20 mg/glove | Passed |
2) Biocompatibility Testing Summary:
| Test Method | Test Purpose | AcceptanceCriteria | Test Results | Conclusion |
|---|---|---|---|---|
| ISO 10993-10Biological evaluationof medical devices -Part 10: Tests for | To evaluate thepotentialintracutaneousreactivity causedby | Under the conditionsof study not anirritation | Under theconditions ofstudy not anirritation | Passed |
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| skin irritation andskin sensitization | intracutaneouslyinject the extract torabbits | |||
|---|---|---|---|---|
| ISO 10993-10Biological evaluationof medical devices –Part 10: Tests forskin irritation andskin sensitization | To determine theskin sensitizationpotential in guineapigs. | Under the conditionsof the study not asensitization | Under theconditions ofthe study not asensitization | Passed |
| ISO 10993-11:2017Biological evaluationof medical devices –Part 11: Tests foracute systemictoxicity | The test item wasevaluated foracute systemictoxicity in ICRmouse | Under the conditionsof the study nosystemic toxicity | Under thecondition ofacute systemictoxicity test,the test articledid not showacute systemictoxicity in vivo. | Passed |
2.1 Summary of Clinical Performance Test
No clinical study is included in this submission.
9. Final Conclusion:
The subject device is a safe, as effective, and perform as well as or better than the legally marketed predicated K203191.
§ 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.