(295 days)
Not Found
No
The device is a standard examination glove and the summary does not mention any AI/ML components or functionalities.
No.
The biodegradable nitrile examination glove is intended to prevent contamination between patient and examiner by being worn on the hands, which is a preventive measure rather than a therapeutic one that treats or alleviates a disease or condition.
No
The device is a biodegradable nitrile examination glove, intended to prevent contamination between patient and examiner. Its purpose is protective barrier, not diagnostic.
No
The device is a physical examination glove, which is a hardware medical device, not software.
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 samples taken from the body.
- Device Description: The description focuses on the physical characteristics of the glove (material, size, color, sterility).
- 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 listed are related to the physical properties and safety of the glove (strength, dimensions, hole detection, biocompatibility), not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The biodegradable 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 patient examination gloves, provided as non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.
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, medical purpose
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, Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical ● Gloves
- ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air Oven
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and . Thermoplastic 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 Part11:Tests for . Systemic Toxicity
All tests (Physical Dimensions Test, Freedom from pinholes, Powder Residue, irritation, sensitizer, acute systemic toxicity) passed their respective acceptance criteria.
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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
April 27, 2023
Guangdong Kingfa Sci. & Tech. Co., LTD. Xiaoge Yu Manager No.28, Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China
Re: K221983
Trade/Device Name: Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 8, 2022 Received: April 24, 2023
Dear Xiaoge Yu:
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) K221983
Device Name
Biodegradable Powder Free Nitrile Examination Glove, Blue Color Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color Biodegradable Powder Free Nitrile Examination Glove, Green Color
Indications for Use (Describe)
The biodegradable 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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3
K221983-510(k) Summary
I. Submitter
GUANGDONG KINGFA SCI. & TECH.CO., LTD. No. 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province 511545, China
Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn
Revision date: September 7, 2022
II. Proposed Device
| Device Trade Name | Biodegradable Powder Free Nitrile Examination Glove, Blue Color |
|---|---|
| Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color | |
| Biodegradable Powder Free Nitrile Examination Glove, Green Color | |
| 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 Device
| 510(k) Number: | K162312 |
|---|---|
| Trade name: | Biodegradable Powder Free Nitrile Exam Gloves With Aloe Vera, |
| Green Color | |
| Common name: | Patient Examination Gloves |
| Classification: | Class I |
| Product Code: | LZA |
| Manufacturer | Shen Wei USA Inc. |
IV. Device description
The propose devices is powder free nitrile patient examination gloves, provided as
4
non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.
V. Indication for use
The biodegradable 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.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device
(K221983) | Predicate
device
(K162312) | Discussion |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Biodegradable
Powder Free Nitrile
Examination Glove,
Blue Color
Biodegradable
Powder Free Nitrile
Examination Glove,
Blue Violet Color
Biodegradable
Powder Free Nitrile
Examination Glove,
Green Color | Biodegradable
Powder Free
Nitrile Exam
Gloves With Aloe
Vera,
Green 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 biodegradable
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. | The biodegradable
powder free nitrile
exam gloves with
aloe vera, green
color is a
disposable device
intended
for medical | Same |
| | powder-free, non-sterile device. | purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. | |
| Main Material | Nitrile rubber | Nitrile rubber | Same |
| Color | Blue\Blue violet\Green | Green | Similar |
| Size | X-Small (6.5), Small(7), Medium (8), Large(8.5),X-large(9), XX-large(9.5), | Ambidextrous in different sizes per ASTM D6319-10 Dimensions requirement | Similar
Only the different standard version. This requirement given in the standard is the same. |
| Palm width | X- Small (70±10mm)
Small (80±10mm)
Medium(95±10mm)
Large(110±10mm)
X-large(120±10mm)
XX-large( $\ge$ 120mm) | Ambidextrous in different sizes per ASTM D6319-10 dimensions requirement | Similar
Only the different standard version. This requirement given in the standard is the same. |
| Length | XS(220mm min)
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min)
XXL (230mm min) | Ambidextrous in different sizes per ASTM D6319-10 Dimensions requirement | Similar
Only the different standard version. This requirement given in the standard is the same. |
| | Palm: 0.05mm min | Ambidextrous in | Similar |
| Thickness | Finger: 0.08mm min | different sizes per
ASTM D6319-10
dimensions
requirement | Only the different
standard version.
This requirement
given in the
standard is the
same. |
| 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 | 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. |
| 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 | ≤2.0 mg/gloves | ≤2.0 mg/gloves | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Biodegradation
Properties | Biodegradable | Biodegradable | Same |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the
counter use | Same |
| Biocompatibility | Skin Sensitization-ISO 10993-10
Irritation-ISO 10993-10 | Skin Sensitization-ISO10993-10
Irritation-ISO 10993-10 | Similar |
| | Acute Systemic Toxicity-ISO 10993-11 | | |
Table 1 Comparison of Nitrile Examination Gloves
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6
7
As above comparison, the difference in the reference standard version of the subject and predicate device does not raise additional questions for safety and effectiveness of the device. The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results shows the predicate device meet the specifications of ASTM D 6319. So we consider this as the proposed device is similar to the predicate device.
VII. Non-Clinical Testing
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, Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical ● Gloves
- ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air Oven
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and . Thermoplastic 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 Part11:Tests for . Systemic Toxicity
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical | ||
| Dimensions Test | Extra-Small: | ||
| Length: $\ge$ 220mm Width: 70 $\pm$ 10 mm; | |||
| Small: | |||
| Length: $\ge$ 220mm Width: 80 $\pm$ 10mm; | |||
| Medium: | |||
| Length: $\ge$ 230mm Width: 95 $\pm$ 10mm | |||
| Large: | |||
| Length: $\ge$ 230mm Width: 110 $\pm$ 10mm | |||
| Extra- Large: | |||
| Length: $\ge$ 230mm Width: 120 $\pm$ 10mm | |||
| Extra- Extra- Large: | Pass |
Table 2 Summary of Non-Clinical Performance Testing
8
| | Physical
properties | Length: ≥ 230mm Width: ≥120mm | | | Pass |
|--------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------|--------|------------------------------------------------------------------------------------------------|
| | | Thickness (mm): | | | |
| | | Finger:≥0.05 | | | |
| | | Palm: ≥0.08 | | | |
| | | Before
Aging | Tensile
Strength | ≥14MPa | |
| | | | Ultimate
Elongation | ≥500% | |
| | | After Aging | Tensile
Strength | ≥14MPa | Pass |
| | | | Ultimate
Elongation | ≥500% | |
| ASTM D5151 | Freedom from
pinholes | Meet the requirements of ASTM
D5151 Test for AQL 2.5 | | | Pass |
| ASTM D6124 | Powder Residue | Meet the requirements of ASTM
D6124