(174 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device is described as examination gloves intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is described as "Disposable Nitrile Examination Gloves" intended to prevent contamination, not to diagnose a condition.
No
The device is a physical product (gloves) and the summary describes physical properties and performance tests related to the material and construction of the gloves, 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 taken from the human body.
- Device Description: The description focuses on the physical characteristics of the gloves (material, color, size, sterility). There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the gloves (watertightness, powder content, tensile strength, elongation) and biocompatibility (cytotoxicity, irritation, sensitization). These are relevant to the function of a barrier device, not an IVD.
- Key Metrics: The key metrics are related to the physical and biological safety performance of the gloves, not the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) 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 Disposable Nitrile Examination Gloves are 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.
Product codes
LZA
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: 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
examiners
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
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 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Physical Dimensions Test (ASTM D6319):
Length: > 240/Pass;
Width: S: 86-89 /Pass, M: 96-101/ Pass, L: 107-110/ Pass, XL:116-119/ Pass
Thickness: Finger: 0.10-0.12/Pass, Palm: 0.08-0.09/Pass
Watertightness Test for Detection of Holes (ASTM D5151): 0/125/Pass
Powder Content (ASTM D6124): 0.16-0.23mg/Pass;
Physical properties (ASTM D412):
Before Aging: Tensile Strength 14-32MPa/Pass, Ultimate Elongation 500-638%/Pass;
After Aging: Tensile Strength 14-30MPa/Pass, Ultimate Elongation 401-609%/Pass;
Cytotoxicity (ISO 10993-5): Under conditions of the study, device extract is cytotoxic (failure to meet acceptance criteria for cytotoxicity under ISO 10993-5).
Cytotoxicity (ISO 10993-11): Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
Irritation (ISO 10993-10): Under the conditions of the study, not an irritant/ Pass
Sensitization (ISO 10993-10): Under conditions of the study, not a sensitizer / Pass
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.
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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2022
Chifeng Huawei Medical Science & Technology Co., Ltd % Boyle Wang Offical Correspondent Shanhai Truthful Information Technology Co., Ltd RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K212833
Trade/Device Name: Disposable Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: January 28, 2022 Received: February 1, 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); 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, PhD 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) K212833
Device Name Disposable Nitrile Examination Gloves
Indications for Use (Describe)
The Disposable Nitrile Examination Gloves 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.
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 K212833
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: CHIFENG HUAWEI MEDICAL SCIENCE & TECHNOLOGY CO.,LTD. Address: No. 2-4, Second-stage Standardized Plant, Songshan (Anqing) Industrial Park, Chifeng, China Phone Number: +86-18248056569 Contact: Li Xiaohong Date of Preparation: Oct. 9th,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 Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): 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: GUANG DONG KINGFA SCI. & TECH.CO., LTD. Device: Nitrile examination gloves 510(k) number: K203593
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5.0 Indication for Use
The Disposable Nitrile Examination Gloves are 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.
6.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Standard | Subject Device
(K212833) | Predicated Device
(K203593) | Comparison | |
|-----------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | / | LZA | LZA | Same | |
| Regulation No. | / | 21CFR880.6250 | 21CFR880.6250 | Same | |
| Class | / | / | / | Same | |
| Intended Use | / | The Disposable Nitrile
Examination Gloves 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. | 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. | Same | |
| Material | / | Nitrile | Nitrile | Same | |
| Powdered or
Powered free | / | Powdered free | Powdered free | Same | |
| Design Feature | / | Ambidextrous | Ambidextrous | Same | |
| Colorant | / | Blue | Blue | Same | |
| 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
) | As Requirements of
ASTM 6319:
Length:
S:≥220;
M/L/XL: ≥230: | Length(mm):
240;
Width(mm):
S: Average 88mm
M: Average 99mm | Length:
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min) | Similar | |
| | Width:
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 | | L: Average 108mm
XL: Average 118mm | Width:
Small (80±10mm)
Medium (95±10mm)
Large (110±10mm)
X large (120±10mm) | |
| | | | As Requirements of | | |
| Thickness
(mm) | ASTM 6319:
Finger: ≥0.05;
Palm: ≥0.05 | | Finger: 0.10-0.12
Palm: 0.08-0.09 | Palm: 0.05mm min
Finger: 0.05mm min | Similar |
| Physical
Properties | Before
Aging | Tensile
Strength | 14-32MPa | 14MPa, min | Similar |
| | | 14MPa,
min | | | |
| | | Ultimate
Elongation | 500-638% | 500% min | Similar |
| | After
Aging | 500% min | | | |
| | | Tensile
Strength | 14-30MPa | 14MPa, min | Similar |
| | | 14MPa,
min | | | |
| | | Ultimate
Elongation
400% | 401-609% | 400%min | Similar |
| | | min | | | |
| | | | Be free from holes when
tested in accordance
with ASTMD 5151
AQL=2.5 | Be free from holes when
tested in accordance
with ASTMD5151
AQL=2.5 | |
| Freedom from
Holes | ASTMD5151 | | | | Same |
| Powder Content | ASTM D6124
240/Pass; | |
| | | Width(mm):
S: 80 $\pm$ 10; | Width(mm):
S: 86-89 /Pass | |
| | | M: 95 $\pm$ 10; | M: 96-101/ Pass | |
| | | L: 110 $\pm$ 10; | L: 107-110/ Pass | |
| | | XL: 120 $\pm$ 10 | XL:116-119/ Pass | |
| | | Thickness (mm): | Thickness (mm): | |
| Finger: ≥0.05 | | | Finger: 0.10-0.12/Pass | |
| Palm: ≥0.05 | | | Palm: 0.08-0.09/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
2.0mg | 0.16-0.23mg/Pass; | |
| ASTM
D412 | Physical
properties | Before Aging | Tensile
Strength
≥14MPa | 14-32MPa/Pass; |
| | | | Ultimate
Elongation
≥500% | 500-638%/Pass; |
| | | After Aging | Tensile
Strength
≥14MPa | 14-30MPa/Pass; |
| | | | Ultimate
Elongation
≥400% | 401-609%/Pass; |
| ISO
10993-5 | Cytotoxicity | In Vitro Cytotoxicity Test | Under conditions of
the study, device
extract is cytotoxic | |
| ISO
10993-11 | Cytotoxicity | Non- acute systemic toxicity | Under conditions of
the study, did not
show acute systemic
toxicity in vivo / Pass | |
| ISO
10993-10 | Irritation | Non-irritating | Under the conditions
of the study, not an
irritant/ Pass | |
| ISO
10993-10 | Sensitization | Non-sensitizing | Under conditions of
the study, not a
sensitizer / Pass | |
Table 2 - Summary of non-clinical performance testing
7
9.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device
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Disposable Nitrile Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicated device K203593.