(79 days)
Not Found
No
The device is a standard medical glove and the summary contains no mention of AI or ML.
No
The device, an examination glove, is intended to prevent contamination, not to diagnose, treat, or mitigate a disease or condition.
No
The device, a Blue Nitrile Exam Glove, is intended to prevent contamination between patient and examiner and does not perform any diagnostic function.
No
The device is a physical examination glove made of nitrile, which is a hardware component, not software.
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 or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description confirms it's a "powder free nitrile examination glove." This is a physical barrier device.
- Lack of Diagnostic Function: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing any diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical properties of the glove (tensile strength, elongation, freedom from holes, powder content) and biocompatibility, which are relevant to a barrier device, not a diagnostic one.
- Key Metrics: The key metrics are physical properties of the glove, not diagnostic performance metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
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
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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, 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.
March 31, 2021
Real Star Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K210057
Trade/Device Name: Blue Nitrile Exam Glove, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 4, 2021 Received: January 11, 2021
Dear Boyle Wang:
We have reviewed vour 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.
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
1
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.
Jiangsong Jiang -S (Affiliate)
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 Ouality Center for Devices and Radiological Health
Enclosure
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3
510(k) Summary (K210057)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Real Star Medical Technology Co., Ltd. Name: Address: Youdi Industry Park in Dongying District, Dongying City 257100, Shandong, China. Phone Number: +86-13953305660 Contact: Nie Jian Date of Preparation: Jan.04,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Blue Nitrile Exam Glove, Powder Free 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
Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422
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5.0 Indication for Use
The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
(K210057) | Predicated Device
(K171422) | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | | | Same |
| Intended Use | The Blue Nitrile
Exam Glove,
Powder Free is a
non-sterile
disposable device
intended for
medical purposes
that is worn on the
examiner's hands
or finger to prevent
contamination
between patient
and examiner. | The Nitrile Powder
Free patient
examination glove
is a non-sterile
disposable device
intended for
medical purposes
that is worn on the
examiner's hands
or finger 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, Nitrile
Glove Powder | Single-use
indication, powder
free, device color,
device name, glove
size and quantity,
Disposable Powder
Free Nitrile | Same |
Table1-General Comparison
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| | Free Blue, Non-
Sterile | Examination Glove,
Non-Sterile | |
| -- | ---------------------------- | ----------------------------------- | -- |
|---|
| Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|
| Predicate | |||||||
| Device(K171422) | Length, mm | XS | |||||
| 230 | S | ||||||
| 230 | M | ||||||
| 230 | L | ||||||
| 230 | XL | ||||||
| 230 | min | ||||||
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Designation | Size | Tolerance | |||||
| Subject Device | |||||||
| (K210057) | Length, mm | S | |||||
| 230 | M | ||||||
| 230 | L | ||||||
| 230 | XL | ||||||
| 230 | $\pm 10$ | ||||||
| Width, mm | 80 | 95 | 110 | 120 | $\pm 10$ | ||
| Thickness, mm: | |||||||
| Finger | 0.08 | $\pm 0.03$ | |||||
| Palm | 0.08 | $\pm 0.03$ | |||||
| Remark | SIMILAR |
Table2 Device Dimensions Comparison
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19,so the differences do not raise any new safety or performance questions.
Table3 Performance Comparison
| Item | Subject device
(K210057) | Predicated device
(K171422) | Remark | | |
|------------------------|-----------------------------------------|-----------------------------------------|------------------------------|------------|------|
| Colorant | Blue | White/ Blue/
Black/ Pink | Same | | |
| 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 | Be free from
holes when
tested in | Same | | |
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| | accordance
with
ASTMD5151
AQL=2.5 | accordance
with
ASTMD5151
AQL=2.5 | |
|----------------|--------------------------------------------|----------------------------------------------|------|
| Powder Content | 0.03 mg per
glove | Meet the
requirements
of ASTM
D6124 | Same |
Table4 Safety Comparison
| Item | Subject device
(K210057) | Predicated
device
(K171422) | Remark | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO
10993-10:2010
Biological
Evaluation of
Medical Devices -
Part 10: Tests For
Irritation And Skin
Sensitization)
Sensitization
(ISO 10993-
10:2010
Biological
Evaluation of
Medical Devices -
Part 10: Tests For
Irritation And Skin
Sensitization) | Under the
conditions of
the study, not
an irritant
Under
conditions of
the study, not
a sensitizer. | Comply with
ISO10993-
10 | Same |
| | Cytotoxicity (ISO
10993-5:2009
Biological
Evaluation of
Medical Devices -
Part 5: Tests For
In Vitro
Cytotoxicity) | Under
conditions of
the study,
device
extract is not
cytotoxic | / | Similar |
8.0 Discussion of Non-clinical and Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device
7
complies with the following standards:
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
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
9.0 Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Blue Nitrile Exam Glove, Powder Free, is as safe, as effective, and performs as well as or better than the legally marketed predicated device cleared under K171422.