(156 days)
No
The 510(k) summary describes a standard medical glove and makes no mention of AI or ML technology.
No
Explanation: A therapeutic device is used to treat or cure a disease or condition. These gloves are used for protection to prevent contamination, not for treatment.
No
Justification: The device (nitrile examination gloves) is used to prevent contamination between patient and examiner, not to diagnose a condition or disease. Its function is protective.
No
The device is a physical product (gloves) and the description focuses on material properties and physical testing, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and standards related to gloves (powder-free, nitrile, color, ASTM standards). There is no mention of analyzing samples from the body or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of that.
- Performance Studies: The performance studies focus on the physical integrity and safety of the glove (irritation, holes, dimensions, etc.), which are relevant to a barrier device, not a diagnostic one.
This device is a medical device, specifically a Class I or Class II medical device (depending on the specific classification of examination gloves), but it is not an IVD.
N/A
Intended Use / Indications for Use
The Disposable Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The proposed device is Powder Free Nitrile Examination 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.
-
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- Purpose: To assess possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.
- Acceptance Criteria for Skin Sensitization Test: provided grades less than 1, otherwise sensitization.
- Results for Skin Sensitization Test: All grades are 0. All animals were survived and no abnormal signs were observed during the study.
- Acceptance Criteria for 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.
- Results for 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: To describe test methods to assess the in vitro cytotoxicity of medical devices.
- Acceptance Criteria: The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to =220 mm; S: width 80+/-10mm, Length >=220 mm; M: width 95+/-10mm, Length >=230 mm; L: width 110+/-10mm, Length >=220 mm; XL: width 75+/-6mm, Length >=220 mm. Thickness: Finger >=0.05 mm, Palm >=0.05 mm.
- Physical properties: Before aging: Tensile strength >=14MPa, Ultimate Elongation >=500%. After Accelerated Aging: Tensile strength >=14MPa, Ultimate Elongation >=400%.
- Powder-free Residue: pl. Refer to No. 4 in table 5.
- Results:
- N.A.
- Please refer to No. 5 in table 5.
- Dimensions: XS: Average width 71.38 mm, Average Length 221.25 mm, Thickness: Average Finger 0.05 mm, Average Palm 0.07 mm; S: Average width 82.63 mm, Average Length 221.12 mm, Thickness: Average Finger 0.055 mm, Average Palm 0.066 mm; M: Average width 93.4 mm, Average Length 232.13 mm, Thickness: Average Finger 0.053 mm, Average Palm 0.079 mm; L: Average width 102.75mm, Average Length 231.4 mm, Thickness: Average Finger 0.054 mm, Average Palm 0.076 mm; XL: Average width 115.4mm, Average Length 231.7 mm, Thickness: Average Finger >=0.054 mm, Average Palm >=0.08 mm.
- Physical properties: Before aging: Average Tensile strength 25.4 MPa, Average Ultimate Elongation >=608%. After Accelerated Aging: Average Tensile strength 25MPa, Average Ultimate Elongation 505%.
- Powder-free Residue: pl. Refer to No. 4 in table 5.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2021
Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K203436
Trade/Device Name: Disposable Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: March 18, 2021 Received: March 25, 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.
Bifeng Qian -S
For Ryan Ortega, Ph.D. 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) K203436
Device Name Disposable Nitrile Examination Gloves
Indications for Use (Describe)
The Disposable Nitrile Examination Gloves is a disposable device intended for medical purposes that is 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 K203436
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Shandong Zhushi Pharmaceutical Group Co., Ltd Name: Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Phone Number: +86-15764021131 Contact: Junhui Zhu Date of Preparation: Apr. 27th, 2021
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: Disposable Nitrile Examination Gloves
Common name: Patient Examination Gloves
Classification name: Non-powdered patient examination glove
XS, S, M, L, XL Model(s): 3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Manufacturer: Ever Global (Vietnam) Enterprise Corp Disposable Powder Free Nitrile Examination Glove, White/ Device: Blue/ Black/ Pink Color
4
510(k) number: K171422
5.0 Intended use
The Disposable Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device description
The proposed device is Powder Free Nitrile Examination 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 Summary comparing technological characteristics with predicate device
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| 510(k) number | K203436 | K171422 | Same |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable Nitrile | ||
| Examination 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 Examination 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
5
| 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 | ||||
| XS | S | M | L | XL | |||
| Length, mm | 220 | 220 | 230 | 230 | 230 | min | |
| Width, mm | 70 | 80 | 90 | 100 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | SIMILAR |
Table 2 Device Dimensions Comparison
Table3 Performance Comparison
| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Colorant | blue | White/ Blue/ Black/ Pink | Analysis1 | |
| 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 | 0.02 | Meet the requirements of ASTM D6124 | SIMILAR |
Analysis1: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility and performance tests, the test results shown that the color difference does not affect the safety and efficacy of proposed device.
Table4 Biocompatibility Testing Comparison
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| Material | Nitrile | Nitrile | SAME |
6
| Biocompatibility | Irritation | with | Similar | ||
|---|---|---|---|---|---|
| Irritation | Under the conditions of the study, not an irritant | ||||
| Sensitization | Under conditions of the study, not a sensitizer. | ||||
| Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | with | SIMILAR | ||
| Label and Labeling | Meet FDA's Requirement | Meet | |||
| Requirement | FDA's | SAME |
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.
| 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,
which may
produce skin and | Skin Sensitization
Test:
provided
grades less than 1,
otherwise
sensitization. | All grades are 0.
All animals were survived and no
abnormal signs were observed
during the study. |
| 2 | | 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