(112 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of disposable nitrile gloves, with no mention of AI or ML.
No.
The device, disposable nitrile gloves, is intended to prevent contamination between patient and examiner, serving a protective and barrier function, not a therapeutic one.
No
Explanation: The device is described as "Disposable nitrile gloves" which are "worn on the examiner's hands to prevent contamination between patient and examiner." Its intended use is for protection, not for diagnosing diseases or conditions. The performance studies and device description focus on the physical properties and safety of the gloves, not on any diagnostic capabilities.
No
The device is described as disposable nitrile gloves, which are a physical product and not software. The summary details performance and biocompatibility testing related to the physical properties of the gloves.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatments.
- Device Intended Use: The intended use of these gloves is clearly stated as being worn on the examiner's hands to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic function performed on a specimen.
- Device Description: The description focuses on the physical properties and standards related to the gloves themselves (material, powder content, freedom from holes), not on any diagnostic capabilities.
- Performance Studies: The performance studies listed are related to the physical integrity and biocompatibility of the gloves, not to the analysis of biological specimens.
Therefore, based on the provided information, the Disposable nitrile gloves are a medical device used for protection and barrier purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Disposable nitrile 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 Disposable nitrile 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 / Not Found
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
Non-clinical testing was conducted, including:
- Biocompatibility testing:
- ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. Results: All grades are 0. All animals were survived and no abnormal signs were observed during the study. 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. Results: Viab.% of 100% test article extract is 13.7%. It means the proposed device have potential toxicity to L-929 in the MTT method.
- ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. Results: There was no evidence of systemic toxicity from the extract.
- Physical property testing:
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves. Results: 0.06 mg/glove.
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. Sample number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤7 gloves for water leakage. Results: no glove water leakage found.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. This standard covers requirements for sterility, freedom from holes, dimensions, thickness, physical properties (tensile strength and ultimate elongation before and after aging), and powder-free residue.
- Dimensions: S: width: 84-88 mm, Length 251-261 mm; M: width 91-95 mm, Length 252-256 mm; L: width 103-106 mm, Length 250-256 mm; XL: width 118-121mm, Length 253-261 mm.
- Thickness: Finger 0.14-0.15 mm, Palm 0.08-0.09 mm.
- Physical properties: Before aging: Tensile strength 14.67-26.48 MPa, Ultimate Elongation 585.48% - 846.81%; After Accelerated Aging: Tensile strength 14.40-22.23 MPa, Ultimate Elongation 527.73% - 775.00%.
- Powder-free Residue: Pl. Refer to table 3.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 29, 2021
Jiangsu Jinke Protective Equipment Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608. No.738. Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K211781
Trade/Device Name: Disposable Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 7, 2021 Received: September 23, 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 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
2
Indications for Use
510(k) Number (if known) K211781
Device Name Disposable nitrile gloves
Indications for Use (Describe)
The Disposable nitrile 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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3
510(k) Summary K211781
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: Jiangsu Jinke Protective Equipment Co., Ltd Address: West Shuangyang Road(South Side), Sihong Economic Development Zone, Suqian, Jiangsu, 223900, China Phone Number: +86-18058186617 Contact: Mia Lai Date of Preparation: 2021.05.27
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Disposable nitrile gloves
Common name: Patient Examination Gloves
Classification name: Non-powdered patient examination glove
Model(s): S, M, L, XL 3.0 Classification
LZA Production code: Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Manufacturer: Ever Global (Vietnam) Enterprise Corp
4
Disposable Powder Free Nitrile Examination Glove, White/ Device:
5
Blue/ Black/ Pink Color 510(k) number: K171422
5.0 Intended use
The Disposable nitrile 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 Disposable nitrile 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 Summarv of Technological Charateristic Comparison
| Item | Proposed device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K211781 | K171422 | Same |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable nitrile | ||
| 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, Disposable | |||
| nitrile 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
6
| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K171422) | XS | S | M | L | XL | ||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±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 | ±10 | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Analysis 1 |
Table2 Device Dimensions Comparison
Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19.
| Item | Proposed device | Predicated device | Comparison | ||
|---|---|---|---|---|---|
| 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 | 0.06 mg/glove | Meet the requirements of | |||
| ASTM D6124 | SIMILAR |
Table3 Performance Comparison
Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test.
7
| Item | Proposed device | Predicated device | Comparison | |
|---|---|---|---|---|
| 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 the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | Analysis3 | |
| Systemic toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO 10993-11 Third edition 2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Table 4 Safety Comparison
Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test, the test results show that the proposed device is safe.
8.0 Discussion of non-clinical testing
In summary, the performance testing and biocompaitbility of the subject device was conducted to demonstrate the subject device met the specification and the acceptance criteria in the standards listed below.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification For Disposable nitrile gloves For Medical Application.
ASTM D7160-16, Standard Practice for Determination of Expiration Dating for Medical Gloves
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.
8
| Test
Methodology /
| Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| 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,
which may produce
skin and mucosal
irritation, eye irritation
or skin sensitization. | Skin Sensitization Test:
provided
grades less than 1,
otherwise 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 | All grades are 0.
All animals were survived
and no abnormal signs were
observed during the study.
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 | 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