(95 days)
A disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
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, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim atthe cuff edge.
The examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) Pre-Market Notification for "Nitrile Gloves (Model: NE01)". It does not describe an AI medical device. Therefore, many of the requested fields are not applicable.
Here's the information extracted from the provided text, focusing on the device's acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Test Purpose | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width: For M: 95 ± 10mm For L: 110 ± 10mm For XL: 120 ± 10mm Length: For M: ≥230mm For L: ≥230mm For XL: ≥230mm Thickness: Finger: ≥0.05mm Palm: ≥0.05mm | Width: For M: 93 | Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Properties Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500% After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500% After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Passed |
| ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | Pass at AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | < 2.0 mg/glove | For M: Pass at 0.46 mg/glove For L: Pass at 0.52 mg/glove For XL: Pass at 0.14 mg/glove | Passed |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | 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 the study not a sensitization | Passed |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential in guinea pigs. | Under the conditions of the study not a sensitization | Under the conditions of study not an irritation | Passed |
| ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for 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 conditions of the study no systemic toxicity | Passed |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, or holes). However, the tests reference ASTM and ISO standards, which typically specify sample sizes for their methodologies. The data provenance is implied to be from laboratory testing performed on the "Nitrile Gloves (Model: NE01)" manufactured by BYD Auto Industry Company Limited, based on the context of a 510(k) submission. It is a retrospective study since the tests were conducted prior to submission. The country of origin of the data is not explicitly stated beyond the manufacturing location in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a medical glove, not an AI-powered diagnostic device. The "ground truth" for these tests is based on objective measurements and established standards (ASTM, ISO), not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. The tests involve objective measurements against predefined criteria, not subjective interpretations requiring adjudication.
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:
Not applicable. This is a non-AI medical device (nitrile gloves).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI medical device (nitrile gloves).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests on the nitrile gloves is based on:
- Physical measurements: Dimensions (width, length, thickness).
- Mechanical properties: Tensile strength and ultimate elongation before and after aging.
- Defect detection: Freedom from holes (water tight test).
- Chemical properties: Residual powder.
- Biocompatibility results: Skin sensitization, skin irritation, and acute systemic toxicity results (determined through biological assays).
These are objective, quantifiable standards as defined by ASTM D6319-19 and ISO 10993 series.
8. The sample size for the training set:
Not applicable. This is a non-AI medical device; there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. This is a non-AI medical device; there is no "training set" or ground truth associated with it in the context of an AI algorithm.
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2021
BYD Auto Industry Company Limited % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong China
Re: K212840
Trade/Device Name: Nitrile Gloves (Model: NE01) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 30, 2021 Received: September 7, 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 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) K212840
Device Name Nitrile Gloves (Model: NE01)
Indications for Use (Describe)
A disposable device intended for medical purposes that is worn on the examiner's hand or fingers 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
This summary of 510(K) is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: August 30, 2021
2. Submitter's Information
Sponsor Name: BYD Auto Industry Company Limited Address: No.3001, 3007, Hengping Road, Pingshan, Shenzhen, Guangdong Establishment Registration Number: Applying Post Code: 518119 Contact name: Jianling Liu Tel: +86 0755-89888888-67228 Tel: +86-136 3299 4277 E-mail: Liu.jianling@byd.com
Manufacture Factory:
Company: Hengchang(Dongying) Medical Technology Co.,Ltd. Address: No.26 Xinghe Road, Niuzhuang Town, Dongying Distict, Dongying City Contact name: Jianling Liu Tel: +86-136 3299 4277 E-mail: Liu.jianling@byd.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: regulatory@share-info.com
3. Subject Device Information
Type of 510(k): Traditional Common Name: Polymer Patient Examination Glove
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| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
Classification Name: Non-powdered patient examination glove Trade Name: Nitrile Gloves Model Name: NE01 Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Requlatory Class: Class I
4. Predicate Device Information
Sponsor: Nathan Trading Co., Ltd. Common Name: Polymer Patient Examination Glove Classification Name: Non-powdered patient examination glove Trade Name: LYDUS Nitrile Examination Gloves, Powder Free 510(k) Number: K203191 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, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim atthe cuff edge.
The examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
6. Intended Use / Indications for Use
A disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
7. Technological Characteristic Comparison to predicate device and conclusion
| Elements of Comparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| ------------------------ | ---------------- | ------------------ | -------- |
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| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
| Elements of Comparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| Company | BYD Auto IndustryCompany Limited | Nathan Trading Co., Ltd. | -- |
| 510 (k) Number | K212840 | K203191 | -- |
| Trade Name | Nitrile Gloves | Nitrile Examination Gloves,Powder Free | -- |
| Product Code | LZA | LZA | Same |
| 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 | A disposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfingers to preventcontamination betweenpatient and examiner. | LYDUS Nitrile ExaminationGloves, Powder Free is adisposable device intended formedical purposes that is wornon the examiner's hand orfingers to prevent contaminationbetween patient and examiner. | Same |
| Material of Use | 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, ExtraLarge | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | Same |
| Dimensions(ASTM D6319-19) | Length:For S: $\geq$ 220mmFor M/L/XL: $\geq$ 230mmWidth:For S: 80 $\pm$ 10mmFor M: 95 $\pm$ 10 mmFor L: 110 $\pm$ 10 mmFor XL: 120 $\pm$ 10 mm | Length Min: 230 min(for medium size)Width Min: 95 $\pm$ 10 mm(for medium size) | SameNote 1 |
| Physical Properties | Before Aging: | Before Aging: | Same |
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| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
| Elements of Comparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| (ASTM D6319-19) | Tensile Strength: ≥14MpaUltimate Elongation:≥500%After Aging:Tensile Strength: ≥14MpaUltimate Elongation:≥400% | Tensile Strength: Min 14 MpaUltimate Elongation: Min 500%After Aging:Tensile Strength: Min 14MpaUltimate Elongation: Min 400% | |
| Thickness(ASTM D6319-19) | Palm: ≥0.05mmFinger: ≥0.05mm | 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 (WaterTight -1000 ml)-ASTM D6319-19 (Cross Reference D5151) | Passed | Passed | Same |
| Biocompatibility - SkinSensitization (ISO 10993-10:2010) | Under the conditions of thestudy not a sensitization | Under the conditions of thestudy not a sensitizer | Same |
| Biocompatibility - Skin Irritation(ISO 10993-10:2010) | Under the conditions ofstudy not an irritation | Under the conditions of studynot an irritant | Same |
| Biocompatibility - AcuteSystemic Toxicity (ISO 10993-11: 2017) | Under the conditions of thestudy no systemic toxicity | No systemic toxicity under theexperimental conditionsemployed | Same |
Comparison in Detail(s):
Note 1:
Although the "Dimensions" of subject device is a little difference with predicate devices, but they all met the requirements of the standard ASTM D6319-19..
8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
Performance Testing Summary: 1)
| Test Method | Test Purpose | Acceptance | Test Results | Conclusion |
|---|---|---|---|---|
| ------------- | -------------- | ------------ | -------------- | ------------ |
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| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
| Criteria | ion | |||
|---|---|---|---|---|
| ASMT D6319-19 StandardSpecification for NitrileExamination Gloves forMedical Application -Physical Dimensions Test | To determine thewidth, length, andthickness of thegloves | Width: | Passed | |
| For M: 95 $\pm$ 10mm | For M: 93~96mm | |||
| For L: 110 $\pm$ 10mm | For L: 104-107mm | |||
| For XL: 120 $\pm$ 10mm | For XL:112~116mm | |||
| Length: | ||||
| For M: ≥230mm | For M: 236~239mm | |||
| For L: ≥230mm | For L: 236~239mm | |||
| For XL: ≥230mm | For XL:255~258mm | |||
| Thickness: | For M: | |||
| Finger: ≥0.05mmPalm: ≥0.05mm | Finger:0.06 | |||
| For L:Finger:0.06 | ||||
| For XL:Finger:0.08 | ||||
| ASMT D6319-19 StandardSpecification for NitrileExamination Gloves forMedical Application -Physical Dimensions Test | To determine thetensile strengthand ultimateelongation beforeand afteraccelerationaging | Before Aging:Tensile Strength:≥14MpaUltimateElongation: ≥500%After Aging:Tensile Strength:≥14MpaUltimate | Before Aging:Tensile Strength:≥14MpaUltimate Elongation:≥500%After Aging:Tensile Strength:≥14MpaUltimate Elongation: | Passed |
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| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
| Elongation: ≥400% | ≥400% | |||
|---|---|---|---|---|
| ASTM D6319-19 (ASTMD5151-11) Standard TestMethod for Detection ofHoles in Medical Gloves | To determine theholes in thegloves | AQL 2.5 | Pass at AQL 2.5 | Passed |
| ASMT D6319-19 (ASTMD6124-11) Standard TestMethod for ResidualPowder on MedicalGloves | To determine theresidual powderin the gloves | < 2.0 mg/glove | For M: Pass at 0.46mg/gloveFor L: Pass at 0.52mg/gloveFor XL: Pass at0.14 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 skinirritation and skinsensitization | To evaluate thepotentialintracutaneousreactivity caused byintracutaneously injectthe extract to rabbits | Under theconditions of studynot an irritation | Under theconditions of thestudy not asensitization | 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 ofstudy not anirritation | 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 theconditions of thestudy nosystemic toxicity | Passed |
8.2 Summary of Clinical Performance Test
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No clinical study is included in this submission.
9. Final Conclusion:
The conclusions drawn from the nonclinical test demonstrate that the subject device is a safe, as effective, and perform as well 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.