(100 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
Explanation: The device is an examination glove intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a condition.
No
Explanation: The device is a nitrile examination glove intended as a barrier to prevent contamination, not to diagnose medical conditions. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical product (nitrile examination gloves) and the performance studies are based on physical properties and biocompatibility, not software functionality.
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 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 details the physical characteristics of a glove.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the glove, not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The nitrile examination glove is intended to be worn on the hands of examiner's 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 propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (7"), medium (8"), large (8.5"), X-large (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.
The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.
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's / 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)
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for . Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions .
- ASTM D5151-19, Test Method for Detection of Holes in Medical Gloves .
- . ASTM D6124-06(2017), Test Method for Residual Powder on Medical Gloves
- ASTM D573-04(2019), Test Method for Rubber-Deterioration in anAir Oven .
- ASTM D412-16, Test Methods for Vulcanized Rubber andThermoplastic . Elastomers-Tension
- 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
The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results pass the requirements.
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). 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 19, 2021
Guang Dong Kingfa SCI. & TECH.CO., LTD. % Shelley Li Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555. Jingan Shanghai, 200071 China
Re: K203593
Trade/Device Name: Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 6, 2021 Received: February 16, 2021
Dear Shelley Li:
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.
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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.
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) Unknown
Device Name Nitrile examination gloves
Indications for Use (Describe)
The nitrile examination glove is intended to be worn on the hands of examiner's 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: K203593
I. Submitter
GUANG DONG KINGFA SCI. & TECH.CO., LTD. No.28 Delong Ave., Shijiao Town, Qingcheng District, Qing yuan, Guangdong, China
Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn
Preparation date: Mar. 18, 2021
US Agent
Jeff Zhang Ucl-Reg Service Inc 602 Rockwood Rd Wilmington, DE US 19802 Phone: 516 2311209 Email: us-agent@glomed-info.com
II. Proposed Device
| Device Trade Name | Nitrile examination gloves |
|---|---|
| Common name: | Polymer Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K181106 |
|---|---|
| Trade name: | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| Common name: | Patient Examination Gloves |
| Classification: | Class I |
| Product Code: | LZA |
| Manufacturer: | JiangSu Dongxin Medical Technology Co., Ltd. |
IV. Device description
The propose devices is powder free nitrile examination gloves, provided as non-sterile
4
and disposable device. The proposed devices are blue color and there are four sizes, includes small (7"), medium (8"), large (8.5"), X-large (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.
The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.
V. Indication 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.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device
(K203593) | Predicate device
(K181106) | Discussion |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Nitrile Examination
Gloves | Powder Free Nitrile
Patient Examination
Gloves, Blue Color | - |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
| Indication 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. | Powder Free Nitrile
Patient Examination
Gloves, Blue Color is
a non-sterile
disposable device
intended for medical
purposes that is worn
on the examiner's
hand or finger to
prevent
contamination
between patient and
examiner. | Same |
| Main Material | Nitrile rubber | Nitrile rubber | Same |
| Color | Blue | Blue | Similar* |
| Table 1 Comparison of Natural Rubber Surqical Gloves | ||
|---|---|---|
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| Size | Small, Medium,
Large, X large | Small, Medium,
Large, X large | Same |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Palm width | Small (80±10mm)
Medium (95±10mm)
Large (110±10mm)
X large (120±10mm) | Small (76-90mm)
Medium (89-102mm)
Large (108-119mm)
X large (115-128mm) | Similar
Minor difference
of palm width
does not affect
the intended
use |
| Length | S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min) | 232 mm min for all
size | Similar
The length of
the subject
device is
shorter than the
predicate's |
| Thickness | Palm: 0.05mm min
Finger: 0.05mm min | Palm: 0.08mm
Finger tip: 0.08mm | Similar
The thickness
of the subject
device is
thinner than the
predicates |
| Freedom from
holes | Meets requirements
of the ASTM D6319-
19 | Meets requirements
of the ASTM D6319-
10 | Similar
Only the
different
standard
version. This
requirement
given in the
standard is the
same. |
| Physical
Properties
(before aging) | Meets requirements
of the ASTM D6319-
19
Tensile Strength:
≥14 MPa
Elongation:
≥500% | Meets requirements
of the ASTM
D6319-10
Tensile Strength:
≥14 MPa
Elongation:
≥500% | Similar
Only the
different
standard
version. The
requirements of
physical
properties given
in the standard
are the same. |
| Physical
Properties
(after aging) | Meets
requirements
of the ASTM D6319-
19 | Meets requirements
of the ASTM
D6319-10 | Similar
Only the
different
standard
version. The
requirements of
physical
properties given
in the standard
are the same. |
| Powder
residual |