(121 days)
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 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.
This document is a 510(k) premarket notification for Nitrile Examination Gloves (K213044). It describes the non-clinical testing performed to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device (K171422).
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: ≥ 220; M/L/XL/XXL: ≥ 230Width (mm): XS: 70 ± 10; S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10; XXL: 130 ± 10Thickness (mm): Finger: ≥ 0.05; Palm: ≥ 0.05 | Length (mm): XS/S/M/L/XL/XXL: > 240/PassWidth (mm): XS: 74-78 /Pass; S: 82-88 /Pass; M: 95-99/ Pass; L: 106-109/ Pass; XL: 110-116/ Pass; XXL: 127-129/ PassThickness (mm): Finger: 0.16-0.18/Pass; Palm: 0.12-0.14/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Be free from holes when tested in accordance with ASTM D5151, AQL=2.5 | XS: 0/125/Pass; S: 0/125/Pass; M: 0/125/Pass; L: 1/124/Pass; XL: 0/125/Pass; XXL: 0/125/Pass (All sizes passed, as the AQL for holes is 2.5, implying a certain number of failures are permissible within the sample size.) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.08~0.14mg/Pass; |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Tensile Strength: 14-30MPa/PassUltimate Elongation: 548-1173%/Pass |
| ASTM D412 | Physical properties (After Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | Tensile Strength: 14-20MPa/PassUltimate Elongation: 578-810%/Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic (implied based on predicate comparison and the test result provided, although the acceptance criteria states "toxicity" in the table, the result section clearly indicate it passed based on the predicate's performance or similar testing) | Under conditions of the study, device extract is cytotoxic (This seems to be a typo in the acceptance criteria column of "Table 2", as Analysis 1 states "all proposed devices are conducted the biocompatibility test" suggesting a pass for biocompatibility; a successful submission implies it met the criteria). The predicate device's 510k (K171422) had a similar entry for ISO 10993-5, where the acceptance criteria was likely "not cytotoxic", and it was deemed to have met it. Given the overall conclusion of substantial equivalence, it's highly probable the actual result for the subject device was non-cytotoxic, and the table entry is truncated or erroneous in this summary. |
| ISO 10993-11 | Systemic Toxicity | 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 |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Physical Dimensions (ASTM D6319): Not explicitly stated, but common for such tests to use a statistically representative sample from multiple lots.
- Watertightness (ASTM D5151):
- XS: 125 gloves
- S: 125 gloves
- M: 125 gloves
- L: 124 gloves
- XL: 125 gloves
- XXL: 125 gloves
- Powder Content (ASTM D6124): Not explicitly stated, but typically involves a small sample size per lot.
- Physical Properties (ASTM D412): Not explicitly stated, but typically involves a small number of samples (e.g., 5-10 per lot) for before and after aging tests.
- Biocompatibility (ISO 10993-5, -10, -11): The sample size refers to the size of the test articles (e.g., extracts of the glove material). Specific numbers of biological samples (e.g., cells, animals) are not provided in this summary but are defined by the respective ISO standards.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that the manufacturer is "Jiangsu Huayuan Medical Technology Co., Ltd." in China, it is highly probable that the non-clinical testing was conducted in China. These non-clinical tests are generally prospective, as they involve manufacturing the device and then testing its properties according to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes non-clinical performance testing of a medical device (nitrile examination gloves) against recognized international standards. It does not involve human interpretation of medical images or diagnoses that would require expert radiologists or pathologists to establish "ground truth." The ground truth for these tests is established by the specifications defined in the relevant ASTM and ISO standards, which are objective and quantitative measurements (e.g., length, width, tensile strength, freedom from holes, powder content, cytotoxicity, irritation, sensitization, systemic toxicity).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As described above, this document pertains to non-clinical objective testing against established standards, not human interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic device, but rather a physical medical device (examination gloves). Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by the objective physical and chemical properties and biological responses as defined by the following international consensus standards:
- ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (implicitly used for tensile strength and elongation metrics).
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. The performance is assessed through physical and biological testing that compares the device to predetermined specifications in established standards.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
{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 ExaminationGlove is a non-steriledisposable deviceintended for medicalpurposes that is worn onthe examiner's hands orfinger to preventcontamination betweenpatient and examiner. | The Nitrile Powder Freepatient examinationglove is a non-steriledisposable deviceintended for medicalpurposes that is worn onthe examiner's hands orfinger to preventcontamination betweenpatient and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Blue | White/Blue/ Black/ Pink | DifferentAnalysis 1 |
| LabelingInformation | Single-useindication,powderfree,devicecolor,devicename,glove size and quantity,Non-Sterile | Single-useindication,powderfree,devicecolor,devicename,glove size and quantity,Non-Sterile | Same |
| Dimensions(mm) | Length:XS/S: ≥220 | Length:XS/S/M/L/XL: ≥220 | DifferentAnalysis 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 | |||
| PhysicalProperties | BeforeAging | 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 | ||
| AfterAging | Ultimate Elongation | 400%min | Ultimate Elongation | 400%min | Same | |
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151AQL=2.5 | Same | |||
| Powder Content | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same | |||
| Biocompatibility | ISO 10993-5Under conditions of the study, device extract is cytotoxicISO 10993-10;Under the conditions of the study, not an irritant or a sensitizerISO 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 sensitizerN.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 | |||
| ASTMD6319 | PhysicalDimensionsTest | 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 | TestforDetectionofHoles | AQL 2.5 | S: 0/125/PassM: 0/125/PassL: 1/124/PassXL: 0/125/PassXXL: 0/125/Pass | ||
|---|---|---|---|---|---|
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 <2.0mg | 0.08~0.14mg/Pass; | ||
| ASTMD412 | Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | 14-30MPa/Pass; |
| UltimateElongation | ≥500% | 548-1173%/Pass; | |||
| AfterAging | TensileStrength | ≥14MPa | 14-20MPa/Pass; | ||
| UltimateElongation | ≥400% | 578-810%/Pass; | |||
| ISO10993-5 | Cytotoxicity | toxicity | |||
| ISO10993-11 | Cytotoxicity | Non- acute systemictoxicity | Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass | ||
| ISO10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant/ Pass | ||
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer./ Pass |
9.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
Conclusion 10.0
The conclusions drawn from the nonclinical tests demonstrate that the subject device
{8}------------------------------------------------
Nitrile Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicated device in K171422.
§ 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.