(84 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.
No.
The device is a glove for preventing contamination, not for treating a condition.
No
The device is described as a "Disposable Nitrile Examination Glove" intended to prevent contamination between patient and examiner. There is no indication that it is used to diagnose any condition.
No
The device description clearly states it is a physical product (gloves) and the performance studies focus on physical properties and biocompatibility, 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 or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and standards related to gloves (material, size, color, tensile strength, elongation, etc.). These are characteristics of a physical barrier device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the integrity and safety of the glove itself (watertightness, powder content, tensile strength, biocompatibility tests like cytotoxicity, irritation, and sensitization). These are relevant to a barrier device, not a diagnostic one.
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 fit that description.
N/A
Intended Use / Indications for Use
The Disposable Nitrile 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.
Product codes
LZA
Device Description
The subject device is powder free nitrile patient examination gloves. The subject device is blue color and has 5 models of XS,S, M, L, XL. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. 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 D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
A summary table of non-clinical testing is provided with test methodology, purpose, acceptance criteria, and results. Key results include:
- Physical Dimensions Test (ASTM D6319): Length (XS/S: >=220mm; M/L/XL: >=230mm); Width (XS: 70+/-10mm; S: 80+/-10mm; M: 95+/-10mm; L: 105+/-10mm; XL: 115+/-10mm); Thickness (Finger: >=0.05mm; Palm: >=0.05mm). All sizes passed dimensional requirements.
- Watertightness Test for Detection of Holes (ASTM D5151): AQL=2.5. Results: XS: 2/125 leaks, S: 0/125 leaks, M: 0/125 leaks, L: 1/125 leaks, XL: 0/125 leaks. All passed.
- Powder Content (ASTM D6124): =14MPa, Ultimate Elongation >=500%. All sizes passed.
- After Aging: Tensile Strength >=14MPa, Ultimate Elongation >=400%. All sizes passed.
- Cytotoxicity (ISO 10993-5): Non-cytotoxic. Passed: "Under conditions of the study, did not show potential toxicity to L-929 cells."
- Irritation (ISO 10993-10): Non-irritating. Passed: "Under the conditions of the study, not an irritant."
- Sensitization (ISO 10993-10): Non-sensitizing. Passed: "Under conditions of the study, not a sensitizer."
Clinical testing was not needed for this device.
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.
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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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 25, 2021
Inner Mongolia Cureguard Medical Technology Co.,Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212401
Trade/Device Name: Disposable Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 16, 2021 Received: August 2, 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.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212401
Device Name Disposable Nitrile Examination Glove
Indications for Use (Describe)
The Disposable Nitrile 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.
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 (K212401)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Inner Mongolia Cureguard Medical Technology Co.,Ltd. Name: Address: Room 326, Management Committee of New Industrial Park, Tumote youqi. Baotou. Inner Monqolia Autonomous Region 014100. China. Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: Oct.22,2021
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: Disposable Nitrile Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS,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 Disposable Nitrile 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.
6.0 Device Description
The subject device is powder free nitrile patient examination gloves. The subject device is blue color and has 5 models of XS,S, M, L, XL. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
(K212401) | Predicate Device
(K171422) | Remark |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Indication for Use/
Intended Use | The Disposable Nitrile
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. | 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 |
| Material | Nitrile | Nitrile | Same |
| Powdered or
Powered free | Powder free | Powder free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Blue | White/ Blue/ Black/ Pink | Similar |
| 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 | Same |
| Dimensions(mm) | Length:
XS/S: $\geq$ 220;
M/L/XL: $\geq$ 230;
Width:
XS: 70 $\pm$ 10: | Length:
XS/S: $\geq$ 220; M: $\geq$ 235;
L/XL: $\geq$ 245
Width:
XS: 75 $\pm$ 5: | Similar |
5
| | | S: 80±10;
M: 95±10;
L: 105±10;
XL: 115±10 | S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5 | |
|------------------------|-----------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------|
| Thickness(mm) | | Finger: ≥0.05;
Palm: ≥0.05 | Finger: ≥0.05;
Palm: ≥0.05 | Same |
| | | | | |
| | | Tensile
Strength | Tensile
Strength | Same |
| | Before
Aging | 14MPa, min | 14MPa, min | |
| | | Ultimate
Elongation | Ultimate
Elongation | Same |
| Physical
Properties | | 500% min | 500% min | |
| | | Tensile
Strength | Tensile
Strength | Same |
| | After
Aging | 14MPa, min | 14MPa, min | |
| | | Ultimate
Elongation | Ultimate
Elongation | Same |
| | | 400%min | 400%min | |
| Freedom from
Holes | | Be free from holes when
tested in accordance with
ASTM D5151 AQL=2.5 | Be free from holes when tested
in accordance with
ASTMD5151 AQL=2.5 | Same |
| Powder Content | | Meet the requirements of
ASTM D6124 $230
Width(mm):
XS: 72-74;
S: 80-83
M: 95-98
L: 110-114
XL: 118-121
Pass
XS:
Finger: 0.07-0.10
Palm: 0.08-0.10
S:
Finger: 0.08-0.11
Palm: 0.08-0.11
M:
Finger: 0.08-0.12
Palm: 0.07-0.11
L:
Finger: 0.08-0.12
Palm: 0.08-0.11
XL:
Finger: 0.08-0.12 |
Table 2: Summary of Non-clinical Testing Table
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| Palm: 0.08-0.12 | |||||
|---|---|---|---|---|---|
| Pass | |||||
| ASTM D5151 | Watertightness | ||||
| Test for | |||||
| Detection of | |||||
| Holes | Meet the requirements of | ||||
| ASTM D5151 AQL 2.5 | XS:2/125 leaks | ||||
| S:0/125 leaks | |||||
| M:0/125 leaks | |||||
| L: 1/125 leaks | |||||
| XL: 0/125 leaks | |||||
| Pass | |||||
| ASTM D6124 | Powder | ||||
| Content | Meet the requirements of | ||||
| ASTM D6124 |