(43 days)
Not Found
No
The device is a disposable examination glove, and the summary focuses on its physical properties and biocompatibility, with no mention of AI or ML.
No
The device, a disposable nitrile examination glove, is intended to prevent contamination between patient and examiner, not to treat or alleviate a medical condition.
No
Explanation: The device is a disposable nitrile examination glove, which is used to prevent contamination between the patient and examiner. Its function is protective, not diagnostic. Diagnostic devices are used to identify a condition or disease.
No
The device is a physical product (gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being worn on the examiner's hands to prevent contamination between patient and examiner. This is a barrier function for personal protection and infection control.
- Device Description: The description details a physical barrier (glove) made of nitrile.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not interact with specimens in this way.
- Performance Studies: The performance studies focus on physical properties, watertightness, powder content, and biocompatibility – characteristics relevant to a barrier device, not an IVD.
- Key Metrics: The key metrics listed are also related to the physical properties and safety of a glove, not diagnostic performance metrics like sensitivity or specificity.
The information provided clearly describes a medical device used for personal protection and infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Nitrile Examination Glove 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 (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 five specifications: XS, 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
examiner / medical purposes
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 10993-5, ISO 10993-10, ISO 10993-23, ISO 10993-11, ASTM D6124-06 (Reapproved 2017), ASTM D5151-19, ASTM D6319-19.
Key results from the tests:
- ASTM D6319 (Physical Dimensions Test): Length > 230mm (Pass); Width (XS: 74-77, S: 85-86, M: 94-97, L: 103-108, XL: 114-118) (Pass); Thickness (Finger: 0.08-0.09mm, Palm: 0.06-0.07mm) (Pass).
- ASTM D5151 (Watertightness Test for Detection of Holes): 0/125 (Pass)
- ASTM D6124 (Powder Content): 0.29-0.33mg (Pass)
- ASTM D412 (Physical properties) - Before Aging: Tensile Strength 14-30 MPa (Pass), Ultimate Elongation 509-586 % (Pass). After Aging: Tensile Strength 14-25 MPa (Pass), Ultimate Elongation 418-533 % (Pass).
- ISO 10993-5 (Cytotoxicity): Under conditions of the study, device extract is cytotoxic.
- ISO 10993-11 (Acute systemic toxicity): Under conditions of the study, did not show acute systemic toxicity in vivo. / Pass
- ISO 10993-23 (Irritation): Under the conditions of the study, not an irritant. / Pass
- ISO 10993-10 (Sensitization): Under conditions of the study, not a sensitizer. / Pass
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.
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 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.
December 7, 2022
Anhui Kindguard Medical Supplies 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: K223281
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: October 21, 2022 Received: October 25, 2022
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 and Part 809); 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
Bifeng Qian, M.D., 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) K223281
Device Name Disposable Nitrile Examination Glove
Indications for Use (Describe)
The Disposable Nitrile Examination Glove 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92. The assigned 510(k) number is K223281.
1.0 Submitter's Information
Name: Anhui Kindguard Medical Supplies Technology Co., Ltd Address: Southwest of Intersection of Tonghe RD & HWY 343, The Economic Dvpt. Zone, Si County, 234300 Suzhou, Anhui, PEOPLE'S REPUBLIC OF CHINA Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: Oct.21, 2022
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 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 subject device is powder free nitrile examination gloves. The subject device is blue.
It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Table1-General Comparison | ||||
|---|---|---|---|---|
| Item | Subject Device | |||
| (K223281) | Predicated Device | |||
| (K171422) | Remark | |||
| Product Code | LZA | LZA | Same | |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | |
| Class | I | I | Same | |
| Intended Use / | ||||
| Indications for Use | The Disposable Nitrile | |||
| Examination Glove 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 | |||
| Material | Nitrile | Nitrile | Same | |
| Powdered or | ||||
| Powered free | Powdered free | Powdered free | Same | |
| Design Feature | Ambidextrous | Ambidextrous | Same | |
| Colorant | Blue | White/ Blue/ Black/ Pink | Different | |
| Analysis 1 | ||||
| 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:≥220; M/L/XL:≥230; | Length: | |||
| S/M/L/XL:≥230; | Different | |||
| Analysis 2 | ||||
| Width: | Width: | |||
| XS: 70±10; | XS: 75±5; | |||
| S: 80±10; | S: 85±5; | |||
| M: 95±10; | M: 95±5; | |||
| L: 110±10; | L: 105±5; | |||
| XL: 120±10 | XL: 115±5 | |||
| Thickness(mm) | Finger: ≥0.05; | |||
| Palm: ≥0.05 | Finger: ≥0.05; | |||
| Palm: ≥0.05 | Same | |||
| Physical | ||||
| Properties | Before | |||
| Aging | Tensile | |||
| Strength | Tensile | |||
| Strength | Same | |||
| $14MPa$ , min | $14MPa$ , min | |||
| Ultimate | ||||
| Elongation | Ultimate | |||
| Elongation | ||||
| 500% min | 500% min | Same | ||
| After | ||||
| Aging | Tensile | |||
| Strength | Tensile | |||
| Strength | Same | |||
| $14MPa$ , min | $14MPa$ , min | |||
| Ultimate | ||||
| Elongation | Ultimate | |||
| Elongation | ||||
| 400%min | 400%min | 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 | Meet the requirements of | |||
| ASTM D6124 | Meet the requirements of | |||
| ASTM D6124 | Same | |||
| Biocompatibility | ISO 10993-10; | |||
| Under the conditions of the | ||||
| study, not a sensitizer | ||||
| ISO 10993-23 | ||||
| Under the conditions of the | ||||
| study, not an irritant | ||||
| ISO 10993-5 | ||||
| Under conditions of the study, | ||||
| device extract is cytotoxic | ||||
| ISO 10993-11; | ||||
| Under the | ||||
| condition of acute | ||||
| systemic toxicity test, | ||||
| the test article did not | ||||
| show acute systemic | ||||
| toxicity in vivo | ISO 10993-10; | |||
| Under the conditions of the | ||||
| study, not an irritant or a | ||||
| sensitizer | Different | |||
| Analysis 3 | ||||
| / | / | |||
| / | / | |||
Table1-General Comparison
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Analysis 1: The subject device (Blue) has different color to the predicate device (White/ Blue/ Black/ Pink), but all proposed devices are conducted the biocompatibility test.
Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.
6
Analysis 3: The subject device conducted the irritation test under the ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation, while the predicate device conducted the irritation test under the old edition ISO 10993-10. But under the conditions of the study, both of the devices are not irritant.
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 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation.
ISO 10993-11 Third edition 2017-09, 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
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): | ||
| XS/S: ≥220; | |||
| M/L/XL: ≥230; | |||
| Width (mm): | |||
| XS: 70±10; | |||
| S: 80±10; | |||
| M: 95±10; | |||
| L: 110±10; | |||
| XL: 120±10. | |||
| Thickness (mm): | |||
| Finger: ≥0.05 | Length(mm): |
230/Pass;
Width(mm):
XS: 74-77 / Pass
S: 85-86 / Pass
M: 94-97 / Pass
L: 103-108 / Pass
XL:114-118 / Pass
Thickness (mm):
Finger: |
Table 2 - Summary of non-clinical performance testing
7
| Palm: ≥0.05 | 0.08-0.09/Pass | ||||
|---|---|---|---|---|---|
| Palm: | |||||
| 0.06-0.07/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 |