(91 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of examination gloves, with no mention of AI or ML.
No
The gloves are intended to prevent contamination and are characterized as examination gloves, not for therapeutic purposes.
No
The device is a nitrile examination glove intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical product (nitrile examination gloves) and does not involve any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical characteristics of the glove (material, color, size, sterility).
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the glove, not on diagnostic accuracy.
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 glove does not perform such a function.
N/A
Intended Use / Indications for Use
The nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
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. It can be available in four specifications: S,M,L and XL. 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiners
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, ISO 10993-11:2017, ASTM D6124-06 (Reapproved 2017), ASTM D5151-19, ASTM D6319-19. Key results include:
- Physical Dimensions Test (ASTM D6319): Length > 230/Pass; Width: S: 83-87 /Pass, M: 93-97/ Pass, L: 102-107/ Pass, XL:113-117/ Pass; Thickness: Finger: 0.08-0.09/Pass, Palm: 0.06/Pass.
- Watertightness Test for Detection of Holes (ASTM D5151): 0/125/Pass.
- Powder Content (ASTM D6124): 0.09-0.11mg/Pass.
- Physical properties (ASTM D412): Before Aging Tensile Strength: 14.24-22.44MPa/Pass; Ultimate Elongation: 507-752%/Pass; After Aging Tensile Strength: 14.23-20.25MPa/Pass; Ultimate Elongation: 505-763%/Pass.
- Cytotoxicity (ISO 10993-11): Under conditions of the study, did not show acute systemic toxicity in vivo / Pass.
- Irritation (ISO 10993-10): Under the conditions of the study, not an irritant/ Pass.
- Sensitization (ISO 10993-10): Under conditions of the study, not a sensitizer./ Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics reported from non-clinical testing:
- Length: S:≥220; M/L/XL:≥230 mm
- Width: S: 80±10; M: 95±10; L: 110±10; XL: 120±10 mm
- Thickness: Finger: ≥0.05; Palm: ≥0.05 mm
- Tensile Strength (Before Aging): 14MPa, min
- Ultimate Elongation (Before Aging): 500% min
- Tensile Strength (After Aging): 14MPa, min
- Ultimate Elongation (After Aging): 400%min
- Freedom from Holes: AQL=2.5 per ASTMD5151
- Powder Content:
§ 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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
November 26, 2021
Wuhan Huirui Technology Co., Ltd Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212722
Trade/Device Name: 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: August 24, 2021 Received: August 27, 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.
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,
For Clarence W. Murray, III, Ph.D. 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) K212722
Device Name Nitrile Examination Gloves
Indications for Use (Describe)
The nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
| 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 - K212722
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Wuhan Huirui Technology Co., Ltd Name: Address: Building 29-1 and 29-2, wuhan Dianjing School. Teyihao Community, Wangjiadian, Jiufeng Street, Jiufeng Township, Wuhan East Lake High-Tech Development Zone, Wuhan. Hubei Province. China Phone Number: +86-18186661114 Contact: Jing Li Date of Preparation: Aug.24th,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Nitrile Examination 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
Manufacturer: GUANG DONG KINGFA SCI. & TECH.CO., LTD. Device: Nitrile examination gloves 510(k) number: K203593
5.0 Indication for Use
4
The disposable medical nitrile examination gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
6.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicated Device
(K203593) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Intended Use | The nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. | The nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. |
| Material | Nitrile | Nitrile |
| Powdered or
Powered free | Powdered free | Powdered free |
| Design Feature | Ambidextrous | Ambidextrous |
| Colorant | Blue | Blue |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile |
| Dimensions(mm) | Length:
S:≥220;
M/L/XL: ≥230;
Width:
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 | Length:
S:≥220;
M/L/XL: ≥230;
Width:
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 |
Table1-General Comparison
5
| Thickness(mm) | | Finger: ≥0.05;
Palm: ≥0.05 | | Finger: ≥0.05;
Palm: ≥0.05 | |
|------------------------|-----------------|---------------------------------------------------------------------------------------------------------------------|------------|-------------------------------|------------|
| Physical
Properties | Before
Aging | Tensile Strength | 14MPa, min | Tensile Strength | 14MPa, min |
| | | Ultimate Elongation | 500% min | Ultimate Elongation | 500% min |
| | After
Aging | Tensile Strength | 14MPa, min | Tensile Strength | 14MPa, min |
| | | Ultimate Elongation | 400%min | Ultimate Elongation | 400%min |
| Freedom from Holes | | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | | | |
| Powder Content | | Meet the requirements of ASTM D6124 | | | |
| Biocompatibility | | ISO 10993-10; | | | |
| | | Under the conditions of the study, not an irritant or a sensitizer | | | |
| | | ISO 10993-11; | | | |
| | | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | | | |
| | | ISO 10993-5
Under conditions of the study, device extract is cytotoxic | | | |
8.0 Summary of Non-clinical Testing
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 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests
for systemic toxicity.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
6
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
| Test
| Method | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| ASTM | ||||
| D6319 | Physical | |||
| Dimensions | ||||
| Test | Length(mm): | |||
| S:≥220; | ||||
| M/L/XL:≥230; | Length: |
230/Pass; | |
| | | Width(mm):
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 | Width:
S: 83-87 /Pass
M: 93-97/ Pass
L: 102-107/ Pass
XL:113-117/ Pass | |
| | | Thickness (mm):
Finger: ≥0.05
Palm: ≥0.05 | Finger: 0.08-0.09/Pass
Palm: 0.06/Pass | |
| | | | | |
| | | | | |
| ASTM
D5151 | Watertightness
Test for
Detection of
Holes | Meet the requirements of ASTM
D5151 AQL 2.5 | 0/125/Pass | |
| ASTM
D6124 | Powder
Content | Meet the requirements of ASTM
D6124