(92 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and performance of disposable nitrile gloves, with no mention of AI or ML.
No
The device, a disposable nitrile glove, is intended for examination purposes to prevent contamination, not to treat or alleviate a medical condition.
No
Explanation: The provided text explicitly states that the device, Disposable Nitrile Glove, is intended to be worn on the examiner's hand to prevent contamination. There is no mention of it being used to diagnose any condition or disease. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical glove made of nitrile, intended to be worn on the hand. It also references performance testing based on a standard for physical gloves (ASTM D6319-19). There is no mention of software components or functionality.
Based on the provided information, 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 hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description reinforces the barrier function and mentions physical properties and standards related to gloves, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical integrity and properties of the gloves (dimensions, strength, freedom from holes), which are relevant to their barrier function, not 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 device does not fit that description.
N/A
Intended Use / Indications for Use
The Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The Disposable Nitrile Gloves are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue or black color, powder free, nitrile ambidextrous gloves. The gloves are offered in large (L) size, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A Biocompatibility
The following tests for the subject device were conducted the biocompatibility of Disposable Nitrile Gloves:
- ISO 10993-5: In Vitro Cytotoxicity
- ISO 10993-23: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- ISO 10993-11: Acute Systemic Toxicity
A Performance Testing
Performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- 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
| Test Method | Purpose | Acceptance Criteria | Results (Blue & Black) |
|---|---|---|---|
| Dimensions (width) (thickness) ASTM D6319-19 | The purpose of the test is to evaluate the physical dimension of the glove | Width 110 ±10mm Length 230mm min Palm - 0.05mm min. Finger-0.05mm min. | Pass 106mm min width 250mm min length Pass Palm – 0.06mm min. Finger-0.12mm min |
| Physical properties ASTM D6319-19 | The purpose of the test is to evaluate the tensile strength and ultimate elongation before and after aging | Tensile Strength: Before Aging ≥ 14 MPa, min. After Aging ≥ 14 MPa, min. Elongation: Before Aging 500%, min. After Aging 400%, min. | Pass Tensile Strength: Before Aging 19.07MPa, min. After Aging 18.11 MPa, min. Elongation: Before Aging 586.47%, min. After Aging 469.20%, min. |
| Freedom from holes ASTM D5151-19 | The purpose of the test is to detect holes in the gloves | No leakage at sampling level of G-1, AQL 2.5 | Pass No leakage, 125 of 125 passed of each color |
| Residual Powder ASTM D6124-06 (Reapproved 2017) | The purpose of the test is to detect the powder residue in the glove |
§ 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
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May 31, 2023
Huizhou Anboson Technology Co., Ltd. % Ivv Wang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai. 200122 China
Re: K230542
Trade/Device Name: Disposable Nitrile Gloves (ABC-DG01) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 5, 2023 Received: May 5, 2023
Dear Ivy 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 medical devices and radiation-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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230542
Device Name Disposable Nitrile Gloves (ABC-DG01 )
Indications for Use (Describe)
The Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand 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
(As requirement by 21 CFR 807.92)
K230542
Date prepared: 2023-05-05
A. Applicant:
Name: Huizhou Anboson Technology Co., Ltd.
Address: 2F, No.7, Hechang East Fourth Road, Zhongkai High-tech Zone, Huizhou City, Guangdong, 516001 China
Contact: Ms. Xuanli Weng Title: Manager Tel: +86-752-2607756
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Disposable Nitrile Gloves Common Name: Nitrile Patient Examination Gloves (Powder Free) Model: ABC-DG01
Regulatory Information Classification Name: Non-powdered patient examination glove Classification: Class I Product code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
C. Predicate device:
K171422 Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color Ever Global (Vietnam) Enterprise Corp
D. Indications for use of the device:
4
The Disposable Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
E. Device Description:
The Disposable Nitrile Gloves are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue or black color, powder free, nitrile ambidextrous gloves. The gloves are offered in large (L) size, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.
| Table 1 General Comparison of Proposed and Predicate Devices | |||
|---|---|---|---|
| Device | Proposed Device | Predicate Device | Result |
| 510K # | K230542 | K171422 | - |
| Product Name | Disposable Nitrile Gloves | Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color | - |
| Product Code | LZA | LZA | Same |
| Classification | Class I | Class I | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for use | The Disposable Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand 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 |
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Singe use | Single use | Same |
| Label | Single-use, indication, powder free, device color, device name, glove size and quantity, Disposable Nitrile Glove, Non-Sterile | Single-use, indication, powder free, device color, device name, glove size and quantity, Disposable Powder Free Nitrile Examination Glove, Non- | Same |
Table 1 General Comparison of Proposed and Predicate Devices
F. Summary of Technological Characteristics
Table 2 Device dimension comparison
| Predicate
| device | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL |
Sterile
5
| (K171422) | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
|---|---|---|---|---|---|---|---|
| Width, mm | 75 | 85 | 90 | 105 | 115 | $\pm$ 5 | |
| Thickness, mm | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Size | |||||||
| Designation | |||||||
| L | Tolerance | ||||||
| Proposed | |||||||
| device | |||||||
| K230542 | Length, mm | 230 | min | ||||
| Width, mm | 110 | $\pm$ 10 | |||||
| Thickness, mm | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Result | Similar |
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.
The proposed device has less size than that of the predicate device, while this difference will not affect the safety or performance of the proposed device.
| Item | | | Proposed
device (K230542) | Predicate
device (K171422) | Result | |
|------------------------|------------------------|---------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------|---------|
| Colorant | | | | Blue/ Black | White/ Blue/ Black/ Pink | Similar |
| 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
ASTM D5151
G-1, AQL 2.5 | Be free from holes when
tested in accordance
with ASTM D5151
G-1, AQL 2.5 | Same | |
| Residual Powder | | | Meet the
requirements of
ASTM D6124 | Meet the requirements
of ASTM D6124 | Same | |
Table 3 Performance comparison
Analysis: The subject device is available in blue or black color; however, the predicate is available in multiple colors (white, blue, black, pink). Biocompatibility testing was successfully completed for the subject device, demonstrating that any color differences do not affect the safety of the proposed device.
Table 4 Biocompatibility comparison
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| Item | Proposed
device (K230542) | Predicate device
(K171422) | Result | |
|------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation
ISO 10993-23 | Under the conditions of the
study, not an
irritant. | Comply with ISO
10993-10 | Same |
| | Sensitization
ISO 10993-10 | Under the
conditions of the
study, not a
sensitizer. | | |
| | In Vitro
Cytotoxicity
ISO 10993-5 | Under the
conditions of the
study, the test
article extract
showed
potential toxicity. | Not available | Different |
| | Acute Systemic
Toxicity
ISO 10993-11 | Under the
conditions of the
study, the device
extract does not
induce acute
systemic toxicity
response. | Not available | Different |
Analysis: In vitro cytotoxicity and acute systemic toxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment.
G. Summary of Non-Clinical Testing
A Biocompatibility
The following tests for the subject device were conducted the biocompatibility of Disposable Nitrile Gloves:
- ISO 10993-5: In Vitro Cytotoxicity
- ISO 10993-23: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Acute Systemic Toxicity
A Performance Testing
Performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
7
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- 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
| Test Method | Purpose | Acceptance Criteria | Results (Blue & Black) |
|---|---|---|---|
| Dimensions | |||
| (width) | |||
| (thickness) | |||
| ASTM | |||
| D6319-19 | The purpose of the test is to | ||
| evaluate the physical | |||
| dimension of the glove | Width 110 ±10mm | ||
| Length 230mm min |
Palm - 0.05mm min.
Finger-0.05mm min. | Pass
106mm min width
250mm min length
Pass
Palm – 0.06mm min.
Finger-0.12mm min |
| Physical
properties
ASTM
D6319-19 | The purpose of the test is to
evaluate the tensile
strength and ultimate
elongation before and after
aging | Tensile Strength:
Before Aging ≥ 14 MPa,
min.
After Aging ≥ 14 MPa,
min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Pass
Tensile Strength:
Before Aging 19.07MPa,
min.
After Aging 18.11 MPa,
min.
Elongation:
Before Aging 586.47%, min.
After Aging 469.20%, min. |
| Freedom
from holes
ASTM D5151-
19 | The purpose of the test is to
detect holes in the gloves | No leakage at sampling
level of G-1, AQL 2.5 | Pass
No leakage, 125 of 125
passed of each color |
| Residual
Powder
ASTM
D6124-06
(Reapproved
2017) | The purpose of the test is to
detect the powder residue
in the glove |