(58 days)
The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Disposable Medical Nitrile Examination Gloves (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.
The provided text describes the 510(k) clearance for "Disposable Medical Nitrile Examination Gloves (Model: XYS-001)". This is a Class I medical device (non-powdered patient examination glove), and the submission focuses on demonstrating substantial equivalence to a predicate device.
The "study" described is a series of non-clinical bench tests and biocompatibility tests conducted to meet specific performance standards and criteria. There is no multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance study, or training set information as this is not an AI/software device.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Standard/Test Method | Acceptance Criteria | Reported Device Performance | Conclusion (from document) |
|---|---|---|---|---|
| Freedom from Holes | ASTM D5151 | Any glove that shows a droplet, stream, or other type of water leakage shall be considered to have failed the test. | Did not show a droplet, stream, or other type of water leakage | Pass |
| Physical Dimension Test | ASTM D412, D3767 | L size:Width: 95±10mmLength: 230mm minThickness:Finger 0.05mm minPalm 0.05mm min | L size:Width: 110mmLength: 237mmThickness:Finger 0.142mmPalm 0.082mm | Pass |
| Physical Requirement Test (Before Aging) | ASTM D412, D573 | Tensile Strength: 14 Mpa, min.Elongation: 500% min. | Tensile Strength: 19.1 MpaElongation: 508% | Pass |
| Physical Requirement Test (After Aging) | ASTM D412, D573 | Tensile Strength: 14 Mpa, min.Elongation: 400% min. | Tensile Strength: 25.4 MpaElongation: 517% | Pass |
| Powder Free Gloves | ASTM D6124 | Max. 2.0mg | Average: 0.5mg (for 5 pcs) | Pass |
| In Vitro Cytotoxicity | ISO 10993-5:2009 | If viability is reduced to <70% of the blank, it has a cytotoxic potential. The Viab.% of the 100% extract of the test article is the final result. | Under the condition of the test, the test article was found to be cytotoxic. (Note 3 in document indicated additional testing was performed to determine if systemic toxicity was a concern, which was later addressed.) | - |
| Skin Sensitization | ISO 10993-10:2010 | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. If the response is equivocal, rechallenge is recommended to confirm the results from the first challenge. The outcome of the test is presented as the frequency of positive challenge results in test and control animals. | Under the condition of the test, the test article was found to be non-sensitizing. | - |
| Intracutaneous Reactivity | ISO 10993-10:2010 | The requirements of the test are met if the final test article score is 1.0 or less. | The result showed that the polar and non-polar extract of the final test sample score is less 1.0. | - |
| Acute Systemic Toxicity | ISO 10993-11:2017 | (1) If during the observation period none of the mice treated with the test article extract exhibited a significantly greater biological reactivity than control mice, the test article met the requirements. If two or more animals died, or if abnormal behavior such as convulsions or prostration occurs in two or more animals, or if body weight loss greater than 10 % occurs in three or more animals, the test article did not meet the requirements. (2) If any animals treated with the sample exhibited only slight signs of biological reactivity, and no more than one animal showed gross symptoms of biological reactivity or died, repeat the testing using groups of ten animals. On the repeat test, if all ten animals treated with the test article extract exhibited no scientifically meaningful biological reactivity above the vehicle control animals during the observation period, the test article met the requirements. | Under the condition of the test, the test article was found to be non-systemic toxicity. | - |
2. Sample Sizes Used for the Test Set and Data Provenance
- Freedom from Holes: 200 samples tested.
- Physical Dimension Test: 13 samples tested/size (only "L" size reported in summary).
- Physical Requirement Test: 13 samples tested/L size.
- Powder Free Gloves: 5 samples.
- Biocompatibility Tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity): The specific sample sizes for animals or cell cultures are mentioned within the "Test method" description (e.g., L-929 cells, guinea pigs for sensitization, rabbits for intracutaneous, mice for systemic toxicity - usually groups of 3-5 for initial tests, or 10 for repeat tests according to the standards).
- Data Provenance: Not explicitly stated (e.g., country of origin for the testing labs), but the submitter's address is in Anhui Province, China. The studies are retrospective in the sense that they were completed tests submitted as evidence of performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical glove, and the "ground truth" is established by standard laboratory testing methodologies and objective measurements against defined standards (ASTM and ISO). There are no human experts "establishing ground truth" in the diagnostic sense for this type of device.
4. Adjudication Method for the Test Set
Not applicable. The tests are benchtop, objective measurements with pre-defined pass/fail criteria from international standards. There is no subjective human assessment requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or AI devices where human reader performance is being evaluated with and without AI assistance. This device is a physical barrier (glove).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This is not an AI/software device.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is based on objective measurements against established international standards and specifications (e.g., ASTM D6319-19 for chemical and physical properties, ASTM D5151 for freedom from holes, ASTM D6124 for powder residue, and ISO 10993 series for biocompatibility).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/software device.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 9, 2021
Anhui Xinyisheng Medical Technology Co.,Ltd % Dave Yungvirt, CEO Official Correspondent THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059
Re: K213371
Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Model:XYS-001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 29, 2021 Received: December 2, 2021
Dear Dave Yungvirt :
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
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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,
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) K213371
Device Name
Disposable Medical Nitrile Examination Gloves(Model:XYS-001)
Indications for Use (Describe)
The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand 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)
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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: Oct.11, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Anhui Xinyisheng Medical Technology Co.,Ltd |
|---|---|
| Address: | No.999 North of the intersection of Tonghe Road and G343Road Si County Suzhou City, Anhui Province, China |
| Contact person: | Shyla Tang |
| Title: | Manager |
| E-mail: | shyla@xinlingroup.com |
| Tel: | 86-18012883846 |
2. Device Identification
| 510(K) number: | K213371 |
|---|---|
| Trade/Device Name: | Disposable Medical Nitrile Examination Gloves |
| Size of glove | Large |
| Models: | XYS-001 |
| Common name: | Polymer Patient Examination Glove |
| Regulation Number: | 880.6250 |
| Regulation Name: | Non-powdered patient examination glove |
| Regulation Class: | Class I |
| Panel: | General Hospital |
| Product Code: | LZA |
3. Predicate Device
| 510(K) number: | K192333 |
|---|---|
| Device Name: | Blue Nitrile Examination Gloves Powder Free |
| Manufacturer: | JR Engineering & Medical Technologies (M) SDN.BHD |
| Common name | Polymer Patient Examination Glove |
| Regulation Number: | 880.6250 |
| Regulation Name: | Non-powdered patient examination glove |
| Regulation Class: | Class I |
| Panel: | General Hospital |
| Product Code: | LZA |
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4. Device Description
Disposable Medical Nitrile Examination Gloves (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.
5. Indication for use
The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
6. Summary of the technological characteristics of the device compared to the Predicate Device
Compared to the predicate device, the subject device has the same intended use, similar product design, and similar performance as the predicate device, the summarized comparison information is listed in the following table:
| SE Comparisons | Subject Device | Predicate DeviceK192333 | Remarks | |
|---|---|---|---|---|
| Name | Disposable Medical NitrileExamination Gloves | Blue Nitrile ExaminationGloves Powder Free | / | |
| Model | XYS-001 | / | / | |
| Size | Large | Extra Small, Small,Medium, Large, ExtraLarge | See Note1 | |
| Classification | Class I | Class I | Same | |
| Intended use | The Disposable MedicalNitrile Examination Glovesis disposable deviceintended for medicalpurpose that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer. | JR MEDIC Blue NitrileExamination GlovesPowder Free isdisposable devicesintended for medicalpurpose that are worn onthe examiner's hand toprevent contaminationbetween patient andexaminer. | Same | |
| Dimensions | ASTM D6319-19 | Length Min:230mmWidth Min:110±10mm(for Large size) | Length Min 230 mmWidth Min 95±10mm(for medium size) | Note1 |
| PhysicalProperties | ASTM D6319-19 | Before AgingTensile Strength Min 14MpaUltimate Elongation Min500%After AgingTensile Strength Min 14MpaUltimate Elongation Min400% | Same | |
| Thickness | ASTM D6319-19 | Palm Min 0.05 mmFinger Min 0.05 mm | Palm Min 0.05 mmFinger Min 0.05 mm | Same |
| Powder Free | ASTM D6319-19 | ≤2 mg/glove | ≤2 mg/glove | Same |
| Biocompatibility | ISO 10993-10:2010 | / | Under the condition ofstudy not anirritant | Note 2 |
| ISO 10993-10:2010 | Under the conditions ofthe study, the result showsnoIntracutaneous Reactivity | / | ||
| ISO 10993-10:2010 | Under the conditions ofthe study not a sensitizer | Under the conditions ofthe study not a sensitizer | Same | |
| ISO 10993-5:2009 | Under the conditions ofthe study,cytotoxic.Additional testing wasperformed to determine ifthis was a systemictoxicity concern | Under the conditions ofthe study,cytotoxic.Additional testing wasperformed to determine ifthis was a systemictoxicity concern | SameNote 3 | |
| ISO 10993-11:2017 | Under the condition ofstudy the device extractsdo not pose a systemictoxicity concern | Under the condition ofstudy the device extractsdo not pose a systemictoxicity concern | SameNote 3 | |
| ISO 10993-11:2017 | / | Under the conditions ofthe study, the device didnot demonstrate amaterial mediatedpyrogenicity response. | Note 4 | |
| Power free | Yes | Yes | Same | |
| Single Use | Yes | Yes | Same | |
| Non-Sterile | Yes | Yes | Same | |
| Color | Blue | Blue | Same | |
| Intended use population | Adult | Adult | Same | |
| Wear | ambidextrous | ambidextrous | Same | |
| EXPIRE DATE | Not claim | Included | See Note 5 |
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Note 1:
In this submission, only one size "L" of glove was submitted for clearance and this size "L" of glove has been performed the testing according to the ASTM D6319-19,
Note 2:
According to the ISO 10993-10:2010, we conducted Intracutaneous reactivity test, Note 3:
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We evaluated the In vitro cytotoxicity in accordance with ISO 10993-5:2009s. Additionally we evaluated acute systemic toxicity in accordance with ISO 10993-11:2017.
Note 4:
We do not claim "non-pyrogenic" and we evaluated the biocompatibility per ISO 10993-1, the material mediated pyrogenicity testing is unnecessary.
Note 5:According to FDA guidance, claiming shelf life is non-mandatory.
7. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The following bench testing was conducted to demonstrate that the subject device met the performance specification or the acceptance criteria in the standard or the test methodology provided below in the table. The results demonstrate that the subject device met the performance
specification and the acceptance criteria for the respected standard and test method below : Performance:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
Freedom from Holes- Testing for freedom from holes were conducted in accordance with 2. Test Method ASTM D5151.
- Physical Dimension test -Determine the dimension as directed in Table 2 of ASTM D6319-19.
Physical Requirement Test-Before and accelerated aging, the physical requirement 4. specified in Table 3 of ASTM D6319-19, tests were conducted in accordance with test method ASTM D412 and accelerated aging test were conducted in accordance with Test Method ASTM D573.
- Powder Free Gloves-Determine the powder residue in accordance with Test Method ASTM D6124.
| Stand ard | Test item | Testmethod | Criteria | Result | Conclusion |
|---|---|---|---|---|---|
| ASTM D6319-19 | freedomfrom holes | ASTM D5151 | Any glove that shows adroplet, stream, orother type of waterleakage shall beconsidered to havefailed the test. | Did not show adroplet, stream,or other type ofwater leakage | 200samples tested0 failuresPass |
| PhysicalDimensiontest | ASTM D412ASTM D3767 | L sizeWidth:95±10mmLength:230minThickness:Finger 0.05minPalm 0.05min | Width:110mmLength:237mmThickness:Finger 0.142mmPalm 0.082mm | 13 samples tested/size0 failurePass | |
| PhysicalRequirement Test | ASTM D412ASTM D573 | Tensile Strength:Before Aging 14 Mpa,min. | Tensile Strength:Before Aging19.1 Mpa, | 13 samplestested/L size |
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| After Aging 14 Mpa,min.Elongation:Before Aging 500%After Aging 400% min. | After Aging 25.4Mpa, Elongation:Before Aging 508%After Aging 517% | 0 failure Pass | |||
|---|---|---|---|---|---|
| PowderFree Gloves | ASTM D6124 | Max. 2.0mg | sample quantity:5pcsAverage: 0.5mg | Pass |
Biocompatibility:
-
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.
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 Tests for In vitro cytotoxicity
| Standard | Test item | Test method | Criteria | Results |
|---|---|---|---|---|
| ISO 10993-5:2009 | In VitroCytotoxicity | In this study, mammalian L- 929cells were cultured in vitroaccording to ISO 10993- 5:2009to test the potential cytotoxicityof the test article. The testarticles and the control materialwere separately placed in MEMmedium containing 10% fetalbovine serum, and extracted in a37°C incubator for 24 hours.After the end of the extraction,the cell culture medium in the96-well plate (104 cells/well)cultured for 24 hours wasremoved and replaced with thecorresponding extract, culturedin 37°C, 5%CO2, >90% humidity for 24hours. After the culture, themorphology and cell lysis of thecells were observed under themicroscope, and the cytotoxicityof the test samples wasdetermined byMTT assay. | The 50% extract of the testarticle should have at leastthe same or a higher viabilitythan the 100% extract.Otherwise the test should berepeated.The lower the Viab. % value,the higher the cytotoxicpotential of the test article is.If viability is reduced to <70%of the blank, it has acytotoxic potential.The Viab.% of the 100%extract of the test article isthe final result. | Under the conditionof the test, the testarticle was found tobe cytotoxic |
| ISO 10993-10:2010 | SkinSensitization | we took guinea pigs to observethe skin sensitization of the testarticle according to ISO 10993-10: 2010.The test article were extractedin Constant TemperatureVibrator at | Magnusson and Kligmangrades of 1 or greater in thetest group generally indicatesensitization, providedgrades of less than 1 areseen in control animals. | Under the conditionof the test, the testarticlewas found to be non- |
| 50°C, 60 rpm for 72 h by0.9 % Sodium Chloride Injectionand Sesame Oil. Mix 50:50 (byvolume) stable emulsion ofFreund's complete adjuvant withselected solvent. Intradermalinduction and topical inductionwere operated in the clippedintrascapular region of eachanimal. After the topicalinduction phase was completedon day 14, all test and controlanimals were challenged withthe test sample. The erythemaand edema of the challenge sitewere observed to test thesensitization response of the testarticle. According to theMagnusson and Kligman scales,the response to erythema andedema at each application siteof the skin was described andscored 24hours and 48 hours after thechallenge phase. | If grades of 1 or greater arenoted in control animals, thenthe reactions of test animalswhich exceed the most severereaction in control animals arepresumed to be due tosensitization.If the response is equivocal,rechallenge is recommendedto confirm the results from thefirst challenge. The outcomeof the test is presented as thefrequency of positivechallenge results in test andcontrol animals. | sensitizin g | ||
| Intracutaneous reactivity | Within a 4 h to 18 h periodbefore testing, closely clip the furon the back of the animals,allowing. a sufficient distance onboth sides of the spine forinjection of the extracts.Use the smallest needleappropriate to the viscosity ofthe test material for theintradermal injection. Injectintracutaneously 0.2 mL of theextracts obtained with polarsolvent at five sites and withnon-polar solvent control atanother five posterior sites onone side of each rabbit.Similarly, inject 0.2 mL of polarsolvent control at five sites andnon-polar solvent control atanother five posterior sites onthe contralateral side of eachrabbit. | The requirements of the testare met if the final test articlescore is 1.0 or less. | the result showedthat the polar andnon-polar extract ofthe final testsample score isless 1.0. | |
| ISO 10993-11:2017 | Acutesystemictoxicity | A single dose of test articleextract was injected into thedesignated group of miceintraperitoneally at the dose levelof 50 mL/kg bw. The negativecontrol liquid was injectedsimilarly into the separate groupof designated control mice.Mice were observed for anyadverse clinical reactionsimmediately after injection, andthen the animals were returnedto their cages. The animalswere observed for signs ofsystemic reactions at4,24,48and 72 hours after injection andweighed daily for three daysafter dosing. Any animal founddead or showed abnormalsigns were subjected to grossnecropsy. | (1) If during the observationperiod of an acute systemictoxicity test none of the micetreated with the test articleextract exhibited a significantlygreater biological reactivitythan control mice, the testarticle met the requirements. Iftwo or more animals died, or ifabnormal behavior such asconvulsions or prostrationoccurs in two or more animals,or if body weight loss greaterthan10 %occurs in three or moreanimals, the test article did notmeet the requirements. (2)Ifany animals treated with thesample exhibited only slightsigns of biological reactivity,and no more than one animalshowed gross symptoms ofbiological reactivity or died,repeat the testing using groupsof ten animals. On the repeattest, if all ten animals treatedwith the test article extractexhibited no scientificallymeaningful biological reactivityabove the vehicle controlanimals during the observationperiod, the testarticle met the requirements. | Under the conditionof the test, the testarticle was found tobe non- systemictoxicity |
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8. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated 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.