(87 days)
Not Found
No
The device is a standard medical glove and the summary does not mention any AI or ML components.
No.
The device, Blue Nitrile Exam Gloves, is intended to prevent contamination between patient and examiner and is described as a disposable exam glove. It does not perform any therapeutic action.
No
Explanation: The device, Blue Nitrile Exam Gloves, is intended to prevent contamination and does not perform any diagnostic function.
No
The device description clearly states it is a physical product (gloves) and the performance studies are related to material properties and biological evaluation, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "worn on the examiner's hands to prevent contamination between patient and examiner." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards related to examination gloves (ASTM D6124, ASTM D5151, and ASTM D6319). These standards are relevant to the performance and safety of gloves as a barrier, not to diagnostic testing.
- Performance Studies: The performance studies described (biocompatibility testing, powder residue, hole detection, dimensions, and physical properties) are all related to the safety and integrity of the glove as a barrier device. There are no studies related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions typically associated with IVDs, such as reagents, assays, analytical methods, or the analysis of biological specimens.
In summary, the Blue Nitrile Exam Gloves are classified as a medical device used for barrier protection, not as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Blue Nitrile Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The proposed device is Powder Free Blue Nitrile Exam Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
Study Type: Non-Clinical Performance Testing
Tests conducted:
- ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- Purpose: Assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.
- Skin Sensitization Test: All grades are 0. All animals survived and no abnormal signs were observed during the study.
- Skin Irritation Test: The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition.
- ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- Purpose: Describes test methods to assess the in vitro cytotoxicity of medical devices.
- Results: Viab.% of 100% test article extract is 86.5%. It means the proposed device have no potential toxicity to L-929 in the MTT method.
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- Purpose: Designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves.
- Results: 0.03mg (Acceptance criteria: powder residue limit of 2.0 mg)
- ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.
- Purpose: Covers the detection of holes in medical gloves.
- Sample number: 125 gloves
- Results: no glove water leakage found (Acceptance criteria: AQL: 2.5 (ISO 2859), Criterion ≤ 7 gloves for water leakage)
- ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application.
- Purpose: Covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.
- Results:
- Sterility: N.A.
- Freedom from holes: Please refer to No. 5 in table 5 (ASTM D5151-06 results)
- Dimensions:
- S: width: 83-86 mm, Length 253-266 mm
- M: width 96-98 mm, Length 243-262 mm
- L: width 106-110 mm, Length 247-254 mm
- XL: width 112-118 mm, Length 245-252 mm (Acceptance criteria based on standard)
- Thickness:
- Finger 0.09-0.11 mm
- Palm 0.08-0.11 mm (Acceptance criteria: Finger ≥0.05 mm, Palm ≥0.05 mm)
- Physical properties:
- Before aging: Tensile strength 15.7-17.7 MPa, Ultimate Elongation 532.284% - 552.072% (Acceptance criteria: Tensile Strength 14MPa, min, Ultimate Elongation 500%min)
- After Accelerated Aging: Tensile strength 15.2-17.8 MPa, Ultimate Elongation 525.947% - 548.352% (Acceptance criteria: Tensile strength 14MPa, Ultimate Elongation 400%min)
- Powder-free Residue: Please refer to No. 4 in table 5 (ASTM D6124-06 results)
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics for physical and chemical properties of the gloves were evaluated against specified standards.
- Skin Sensitization Test: All grades are 0.
- Skin Irritation Test: Primary irritation index is 0.
- Cytotoxicity (Viability %): 86.5% (Acceptance criteria: if viability is reduced to
§ 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.
0
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 USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
July 29, 2021
Jiangxi Surefine Medical Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608, No.738, Shangcheng Rd., Pudong Shanghai, 200120 China
Re: K211341
Trade/Device Name: Blue Nitrile Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 6, 2021 Received: July 12, 2021
Dear Boyle Wang:
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.
1
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.
For Clarence W. Murray, III, PhD 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211341
Device Name Blue Nitrile Exam Gloves
Indications for Use (Describe)
The Blue Nitrile Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands 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 21 CFR 807.92.
1.0 submitter's information
Name: Jiangxi Surefine Medical Co., Ltd. Address: Jinshan Rd., Yugan Hi-tech Industrial Park, Shangrao,Jiangxi Province, 335100, China Phone Number: +86-13805860705 Contact: Steve Zhu Date of Preparation: 2021.04.21
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Blue Nitrile Exam Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Ever Global (Vietnam) Enterprise Corp Manufacturer: Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422
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5.0 Intended use
The Blue Nitrile Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device description
The proposed device is Powder Free Blue Nitrile Exam Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
7.0 Technological Characteristics Comparison
| Item | Proposed device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K211341 | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Blue Nitrile Exam Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Blue Nitrile Exam Gloves, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Disposable Powder Free Nitrile Examination Glove, Non-Sterile | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K171422) | XS | S | M | L | XL |
5
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | ||
|---|---|---|---|---|---|---|---|---|
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ | ||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Proposed Device | Designation | Size | Tolerance | |||||
| S | M | L | XL | |||||
| Length, mm | 220 | 230 | 230 | 230 | min | |||
| Width, mm | 80 | 95 | 110 | 120 | $\pm 10$ | |||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Remark | Analysis 1 |
Table3 Performance Comparison
| Item | Proposed device | Predicated device | Remark | ||
|---|---|---|---|---|---|
| Colorant | blue | White/ Blue/ Black/ Pink | Analysis2 | ||
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile | ||||
| Strength | 14MPa, min | 14MPa, min | SAME | ||
| Ultimate | |||||
| Elongation | 500%min | 500%min | SAME | ||
| After | |||||
| Aging | Tensile | ||||
| Strength | 14MPa, min | 14MPa, min | SAME | ||
| Ultimate | |||||
| Elongation | 400%min | 400%min | SAME | ||
| Comply with ASTM D6319 | Comply with ASTM D6319 | SAME | |||
| Freedom from Holes | Be free from holes | ||||
| when tested in | |||||
| accordance with | |||||
| ASTMD5151 | |||||
| AQL=2.5 | Be free from holes when | ||||
| tested in accordance with | |||||
| ASTMD5151 AQL=2.5 | SAME | ||||
| Powder Content | 0.03 | Meet the requirements of | |||
| ASTM D6124 | SIMILAR |
Analysis1: The proposed device has different sizes to the predicate device, but all proposed devices are conducted the properties test, the test results shown that the sizes comply with the requirements of standard ASTM D6319-19, Standard Specification For Blue Nitrile Exam Gloves For Medical Application.
Analysis2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility and performance tests were comparable.
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| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | Comply with ISO10993-5 | SIMILAR | |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Table4 Biocompatibility Testing Comparison
8.0 Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
Table 5 Summary of Non-Clinical Performance Testing
| No. | Name of the Test
Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-----|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-10:2010
Biological Evaluation Of
Medical Devices - Part
10: Tests For Irritation
And Skin Sensitization. | This part of ISO
10993 assesses
possible contact
hazards from
chemicals released from
medical devices, | Skin Sensitization
Test:
provided grades less than 1,
otherwise
sensitization. | All grades are 0.
All animals survived and no
abnormal signs were observed
during the study. |
| 2 | | which may
produce skin and
mucosal irritation,
eye irritation or
skin sensitization. | Skin Irritation Test:
If the primary irritation
index is 0-0,4, the
response category is
Negligible.
0,5-1,9 means slight
2-4,9 means moderate
5-8 means severe | The primary irritation index is 0.
The response of the proposed
device was categorized as
negligible under the test
condition |
| | | | | |
| 3 | ISO 10993-5:2009
Biological Evaluation Of
Medical Devices - Part
5: Tests For In Vitro
Cytotoxicity | This part of ISO
10993 describes
test methods to
assess the in vitro
cytotoxicity of
medical devices. | The viab.% of the
100% extract of the
test article is the final
result, and if viability is
reduced to