(124 days)
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.
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 (S"), medium (M"), large (L"), X-large (XL") for optional. The gloves are provided with blue color. The examination glove is smooth surface 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.
This document is a 510(k) summary for a medical device (ZinRom powder-free nitrile examination gloves), not an AI/ML medical device. Therefore, the requested information (acceptance criteria and study details for an AI/ML device) is not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of physical properties and biocompatibility for a physical product (gloves). It explicitly states "No clinical study is included in this submission."
Consequently, I cannot provide a table of acceptance criteria and reported device performance for an AI/ML device, nor details about sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 6, 2021
Changzhou Xingrong Medical Technology Co. LTD Amber Pang Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, 200071 China
Re: K211719
Trade/Device Name: ZinRom powder-free 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: August 6, 2021 Received: August 13, 2021
Dear Amber Pang:
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, 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) K211719
Device Name
Zinrom powder-free 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)
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-K211719
l. Submitter
CHANGZHOU XINGRONG MEDICAL TECHNOLOGY CO., LTD. No. 528, Daqiaotou, Chaoyang Cunwei, Hengshanqiao Town, Economic Development District, Changzhou
Contact person: Ray Position: Sales Manager Tel.: +86-13775218805 E-mail: ray@zinrom.com
Preparation date: Oct. 7, 2021
II. Proposed Device
| Device Trade Name: | ZinRom powder-free nitrile examination gloves |
|---|---|
| Common name: | 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 and disposable device. The proposed devices are blue color and there are four sizes, includes small (S"), medium (M"), large (L"), X-large (XL") for optional. The gloves are provided with blue color. The examination glove is smooth surface and a rolled rim at the cuff edge.
The gloves are manufactured in accordance with the requirements of ASTM
{4}------------------------------------------------
D6319-19 and Medical Glove Guidance Manual.
V. Indication 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.
VI. Comparison of technological characteristics with the predicate devices
| Item | Standard | Proposed device(K211719) | Predicate device(K181106) | Comparison |
|---|---|---|---|---|
| Product name | - | ZinRom powder-free nitrileexamination gloves | Powder Free NitrilePatient ExaminationGloves, 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 nitrileexamination glove isintended to be wornon the hands ofexaminer's to preventcontaminationbetween patient andexaminer. This is asingle-use, powder- | Powder Free NitrilePatient ExaminationGloves, Blue Color isa non-steriledisposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger toprevent | Same |
| free,non-sterile device. | contaminationbetween patientandexaminer. | |||
| Main Material | ASTM D6319-19 | Nitrile rubber | Nitrile rubber | Same |
| Color | - | Blue | Blue | Similar* |
| Size | ASTM D6319-19 | Small, Medium,Large, X large | Small, Medium,Large, X large | Same |
| Palm width | ASTM D6319-19Width: Range value -S : Width: 80 ± 10 mmM : Width: 95 ± 10 mmL : Width: 110 ± 10mmXL : Width: 120 ± 10mm | Small (83-87 mm)Medium (97-98 mm)Large (103-109 mm)X large (118-120mm) | Small (76-90mm)Medium (89-102mm)Large (108-119mm)X large (115-128mm) | Similar Minordifferenceof palm widthdoes not affectthe intendeduse |
| Length | ASTM D6319-19Length: Range value -S: Length : 220mmmin,M : Length : 230mmmin | S (238-245 mm)M (238-247 mm)L (241-248 mm)XL(231-248 mm) | 232 mm min for allsize | SimilarThe length ofthe predicatedevice is shorterthan thesubject's. |
| L : Length : 230mmmin,XL : Length : 230mmmin, | ||||
| Thickness | ASTM D6319-19For all size: Finger:0.05 minPalm: 0.05 min | Palm: 0.05mm minFinger: 0.05mm min | Thickness (mm) min:Palm: 0.08mmFinger tip : 0.08mm | SimilarThe thickness ofthe subjectdevice is thinnerthan thepredicates |
| Freedom fromholes | ASTM D5151-19ASTM D6319-19Inspection Level IAQL2.5 | Inspection Level IAQL2.5, andAccept criteria Ac 10,Re 11.Pass. | 1) InspectionLevel IAQL2.5,andAccept/Rejectcriteria of 10/112) Water leakagetest: 5noncompliance isallowed | Similar |
| PhysicalProperties(before aging) | ASTM D6319-19ASTM D412-16ASTM D573-04(2019)Before Aging Range:Tensile Strengthmin: > 14 MpaUltimate Elongation | Before aging:Elongation: 500-550%Tensile Strength: 16-24 MPa | Before aging:Elongation: 550-600%Tensile Strength: 18-25 MPa | Similar Only thedifferentstandardversion.Therequirements ofphysicalproperties givenin the standard |
| Min: 500% | are the same. | |||
| PhysicalProperties (afteraging) | ASTM D6319-19ASTM D412-16ASTM D573-04(2019)After Aging Range:Tensile Strength min: >14 Mpa UltimateElongation Min: 400% | After aging:Elongation: 450-520%Tensile Strength: 15-22 MPa | After aging:Elongation: 450-570%Tensile Strength: 17-22 MPa | Similar Only thedifferentstandardversion.Therequirements ofphysicalproperties givenin the standardare the same. |
| Powder residual | ASTM D6319-19ASTM D6124-06(2017)Range:< 2 mg/glove | ≤ 0.4 mg/gloves | 1) Checked on 5pcssub-samples (N=5).2) Result as following:Mean: 0.1mg/pcs | Similar |
| Sterility | - | Non-sterile | Non-sterile | Same |
| For single use | Medical GloveGuidance Manual -Labelling | Yes | Yes | Same |
| Type of use | - | Over the counter use | Over the counter use | Same |
| Shelf-life | ASTM D7160-16 | 3 years | NA | Different |
| 510(k) Summary | ||||
| Biocompatibility- SkinSensitizationTest | ISO 10993-10:2010 | Under the testcondition of study notan sensitizer | Under the testcondition of study notan sensitizer | Same |
| Biocompatibility- Skin IrritationTest | ISO 10993-10:2010 | Under the testcondition of study notan irritant | Under the testcondition of study notan irritant | Same |
| Biocompatibility- CytotoxicityTest | ISO 10993-5:2009 | Under the testconditions, the testarticle was shownpotentialtoxicity to L-929cells. | Under the testconditions, the testarticle was noncytotoxic to L-929cells. | Different |
| Biocompatibility- acute systemictoxicity Test | ISO 10993-11:2017 | Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo. | Unknown | Different |
Table 1 Comparison of Patient Examination Glove
{5}------------------------------------------------
510(k) Summary
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
*As above comparison, the difference in the dimensions and 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 pass the requirements.
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
- ASTM D7160-16, Standard Practice for Determination of Expiration Dating for . Medical Gloves
- . 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
| Test Method | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|
| ASTM D5151ASTM D6319-19 | Testing for Freedomfrom holes | Inspection Level IAQL2.5, andAccept criteria Ac10, Re 11. | Pass. No waterleakage isinspected form 200samples |
| ASTM D6124-06(2017)ASTM D6319-19 | Determine thepowderresidue for powderfreegloves | < 2 mg/glove | ≤ 0.4 mg/gloves |
| 510(k) Summary | |||
| ASTM D412-16ASTM D573-04(2019)ASTM D6319-19 | Testing for Physicalpropertycharacteristics | After Aging Range:Tensile Strengthmin: > 14 MpaUltimate ElongationMin: 400%After Aging Range:Tensile Strengthmin: > 14 MpaUltimate ElongationMin: 400% | Before aging:Elongation: 500-550%Tensile Strength:16-24 MpaAfter aging:Elongation: 450-520%Tensile Strength:15-22 MPa |
| ASTM D412-16ASTM D573-04(2019)ASTM D6319-19 | Testing For physicaldimensionsspecification | Length for size (S);:220 mm min.Length for size (M,L,XL): 230 mm min.Width: 80±10 mmfor S; 95±10 mm forM; 110±10 mm forL; 120±10 mm forXL.Finger Thickness:≥0.05 mm;Palm Thickness:≥0.05 mm;All acceptancecriteria above meettherequirements inTable 1 DimensionsandTolerances of ASTMD6319 | Length of Size S:238-245 mm;Width of Size S: 83-87 mm;Palm Thickness ofSize S: ≥0.05 mm;Finger Thickness ofSize S: ≥0.05 mm.Length of Size M:238-247 mm;Width of Size M: 97-98 mm;Palm Thickness ofSize M: ≥0.05 mm;Finger Thickness ofSize M: ≥0.05 mm.Length of Size L:241-248 mm;Width of Size L:103-109 mm;Palm Thickness ofSize L: ≥0.05 mm;Finger Thickness ofSize L: ≥0.05 mm.Length of Size XL:231-248 mm;Width of Size XL:118-120 mm;Palm Thickness ofSize XL: ≥0.05 mm;Finger Thickness ofSize XL: ≥0.05 mm. |
| ISO 10993-10:2010 | Evaluate theendpoint ofirritant for | The response of thetest article extract isnegligible. | Under the testcondition of studynot an sensitizer. |
| biocompatibility | 510(k) Summary | ||
| Evaluate theendpoint ofsensitization forbiocompatibility | The test articleshowed no evidenceof causing delayeddermal contactsensitization. | Under the testcondition of studynot an irritant. | |
| ISO 10993-5:2009 | Evaluate theendpoint ofCytotoxicity forbiocompatibility | The test articleshowed no evidenceof Cytotoxicity fromthe extract. | Under the testconditions, the testarticle was shownpotentialtoxicity to L-929cells. |
| ISO 10993-11:2017 | Evaluate theendpoint ofSystemicCytotoxicityfor biocompatibility | The test articleshowed no evidenceof systemic toxicityfrom the extract. | Under thecondition of acutesystemic toxicitytest, the test articledid not show acutesystemic toxicity invivo. |
{10}------------------------------------------------
{11}------------------------------------------------
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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.