(121 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, a nitrile examination glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device, Nitrile Examination Glove, is described as a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. Its function is to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a physical product (nitrile examination gloves) and the performance studies focus on physical properties and biocompatibility, not software functionality.
No, 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 hands to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic function.
- Device Description: The description details a physical barrier (glove) with specifications related to size, material, and sterility. There is no mention of reagents, samples, or analysis of biological specimens, which are characteristic of IVDs.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device described is a medical glove, which is a Class I or Class II medical device depending on its intended use and claims, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: XS,S,M,L XL and XXL. 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 or finger
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 10993-5:2009 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.
Summary of non-clinical performance testing:
- ASTM D6319 Physical Dimensions Test: Length, Width, Thickness met acceptance criteria for all sizes (XS, S, M, L, XL, XXL).
- ASTM D5151 Watertightness Test for Detection of Holes: Met requirements of ASTM D5151 AQL 2.5 for all sizes.
- ASTM D6124 Powder Content: Met the requirements of ASTM D6124 (
§ 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.
January 21, 2022
Jiangsu Huayuan Medical 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: K213044
Trade/Device Name: 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: December 7, 2021 Received: December 20, 2021
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.
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
1
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,
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
2
Indications for Use
510(k) Number (if known) K213044
Device Name Nitrile Examination Gloves
Indications for Use (Describe)
The Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K213044
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Jiangsu Huayuan Medical Technology Co.,Ltd. Address: No. 36 Nanzhuang Road, High-Tech Industrial Development Zone of Dongtai City,Jiangsu Province,China Phone Number: +86-18252909158 Contact: Ms.Yun Gao Date of Preparation: Sept.2, 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: Nitrile Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL, XXL
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 Disposable Powder Free Nitrile Examination Glove, White/Blue/ Device: Black/ Pink Color 510(k) number: K171422
4
5.0 Indication for Use
The Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger 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 six specifications: XS,S,M,L XL and XXL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Subject Device | Predicated Device | Remark | |
|---|---|---|---|
| Item | (K213044) | (K171422) | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | Same | ||
| Intended Use | The Nitrile Examination | ||
| Glove is a non-sterile | |||
| disposable device | |||
| intended for medical | |||
| purposes that is worn on | |||
| the examiner's hands or | |||
| finger to prevent | |||
| contamination between | |||
| patient and examiner. | The Nitrile Powder Free | ||
| patient examination | |||
| glove is a non-sterile | |||
| disposable device | |||
| intended for medical | |||
| purposes that is worn on | |||
| the examiner's hands or | |||
| finger 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 | Length: | ||
| XS/S/M/L/XL: ≥220 | Different | ||
| Analysis 2 |
Table1-General Comparison
5
| M/L/XL/XXL: ≥230; | Width: | |||||
|---|---|---|---|---|---|---|
| Width: | XS: 87±5; | |||||
| XS: 70±10; | S: 85±5; | |||||
| S: 80±10; | M: 95±5; | |||||
| M: 95±10; | L: 105±5; | |||||
| L: 110±10; | XL: 115±5 | |||||
| XL: 120±10; | ||||||
| XXL: 130±10 | ||||||
| Thickness(mm) | Finger: ≥0.05; | |||||
| Palm: ≥0.05 | Finger: ≥0.05; | |||||
| Palm: ≥0.05 | Same | |||||
| Physical | ||||||
| Properties | Before | |||||
| Aging | Tensile Strength | 14MPa, min | Tensile Strength | 14MPa, min | Same | |
| Ultimate Elongation | 500% min | Ultimate Elongation | 500% min | Same | ||
| Tensile Strength | 14MPa, min | Tensile Strength | 14MPa, min | Same | ||
| After | ||||||
| Aging | Ultimate Elongation | 400%min | Ultimate Elongation | 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 10993-5 | |||||
| Under conditions of the study, device extract is cytotoxic |
ISO 10993-10;
Under the conditions of the study, not an irritant or a sensitizer
ISO 10993-11;
Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo | | N.A.
ISO 10993-10;
Under the conditions of the study, not an irritant or a sensitizer
N.A. | | /
Same
/ |
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.
6
Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.
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 10993-5:2009 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.
| Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Method | |||
| ASTM | |||
| D6319 | Physical | ||
| Dimensions | |||
| Test | Length(mm): | Length(mm): | |
| XS/S: $\ge$ 220; | XS/S/M/L/XL/XXL: | ||
| M/L/XL/XXL: $\ge$ 230; | > 240/Pass; | ||
| Width(mm): | Width(mm): | ||
| XS: 70 $\pm$ 10; | XS: 74-78 /Pass | ||
| S: 80 $\pm$ 10; | S: 82-88 /Pass | ||
| M: 95 $\pm$ 10; | M: 95-99/ Pass | ||
| L: 110 $\pm$ 10; | L: 106-109/ Pass | ||
| XL: 120 $\pm$ 10; | XL:110-116/ Pass | ||
| XXL: 130 $\pm$ 10 | XXL: 127-129/ Pass | ||
| Thickness (mm): | Thickness (mm): | ||
| Finger: $\ge$ 0.05 | Finger: 0.16-0.18/Pass | ||
| Palm: $\ge$ 0.05 | Palm: 0.12-0.14/Pass | ||
| ASTM | Watertightness | Meet the requirements of ASTM D5151 | XS: 0/125/Pass |
Table 2 - Summary of non-clinical performance testing
7
| D5151 | Test
for
Detection
of
Holes | AQL 2.5 | S: 0/125/Pass
M: 0/125/Pass
L: 1/124/Pass
XL: 0/125/Pass
XXL: 0/125/Pass | | |
|-----------------|-----------------------------------------|------------------------------------------------|--------------------------------------------------------------------------------------|-------------------|---------------------------------------------------------------------------------------------|
| ASTM
D6124 | Powder
Content | Meet the requirements of ASTM D6124