(402 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Nitrile Patient Examination Gloves, Powder Free, Pink Color. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I). These gloves are pink in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL).
The provided text describes the acceptance criteria and the study results for the "Nitrile Patient Examination Gloves, Powder Free, Pink Color" manufactured by Shandong YINGHONG Medical Products Co., Ltd.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method (Purpose) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Dimensions (length, width, thickness) (ASTM D6319-19) - To evaluate the physical dimension of the glove | Length: 220 mm min (XS, S); 230 mm min (M, L, XL, XXL) | Pass (240 mm min) |
| Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; XXL: 130±10 | Pass (XS: average 78.4mm; S: average 86.2mm; M: average 97.4mm; L: average 108.7mm; XL: average 115.5mm; XXL: average 123.5mm) | |
| Thickness(mm): Palm: Minimum 0.05; Finger: Minimum 0.05 | Pass (Palm - 0.056mm min.; Finger - 0.082mm min) | |
| Physical properties (ASTM D6319-19) - To evaluate the tensile strength and ultimate elongation before and after aging | Before Aging: Tensile Strength: 14 MPa, min.; Elongation: 500%, min. After Aging: Tensile Strength: 14 MPa, min.; Elongation: 400%, min. | Pass (Before Aging: Tensile Strength: 20.6MPa, min.; Elongation: 531%, min. After Aging: Tensile Strength: 21.9MPa, min.; Elongation: 416%, min.) |
| Freedom from holes (ASTM D5151-19) - To detect holes in the gloves | In accordance with ASTM D6319-19 and ASTM D5151-19, G-1, AQL 2.5 (Implicit in "Similar" comparison to predicate) | (The specific result for this test is not explicitly stated in the table provided for the subject device, but the comparison table indicates "Similar" to the predicate which met these standards) |
| Residual Powder (ASTM D6124-06) - To detect the powder residue in the glove | <2mg per glove | Pass (Average 0.15 mg per glove) |
| In Vitro Cytotoxicity Test (ISO 10993-5) - To determine the cytotoxic potential of the glove. | Under the conditions of the study, the device is not cytotoxic | Pass (Under the conditions of the study, the device have no cytotoxic effect) |
| Skin Sensitization Test (ISO 10993-10) - To determine the skin sensitization potential of the glove. | Under the conditions of the study, the device is not a sensitizer | Pass (Under the conditions of the study, the device is not a sensitizer.) |
| Skin Irritation Test (ISO 10993-10) - To determine the potential of the glove under test to produce irritation. | Under the conditions of the study, the device is not an irritant | Pass (Under the conditions of the study, the device is not an irritant.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical physical and biocompatibility testing. It cites compliance with ASTM and ISO standards for these tests. For these types of tests, specific sample sizes beyond what the standards prescribe are usually not detailed in the summary. For example, ASTM D6319-19 and ASTM D5151-19 would define the sampling plans. The document mentions "Three Lot" for the residual powder test, suggesting at least three batches were sampled.
The data provenance is from the manufacturer, Shandong YINGHONG Medical Products Co., Ltd., which is located in Qingzhou, Shandong, China. The studies are prospective as they are conducted for the specific purpose of device submission and evaluation against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a patient examination glove and the tests performed are physical and biocompatibility evaluations against established industry standards (ASTM, ISO). These do not involve human interpretation or expert-established ground truth in the way medical imaging or diagnostics might. The "ground truth" is defined by the objective measurement specifications of the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3. Physical and biocompatibility tests are objective and do not typically involve 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
This information is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is an examination glove, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of these gloves is based on established industry standards and regulatory specifications as outlined in ASTM D6319-19, ASTM D6124-06, ASTM D5151-19, ISO 10993-10, and ISO 10993-5. This is objective and measurable, rather than relying on expert consensus or pathology in a clinical diagnostic sense.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of physical and biocompatibility testing of a medical device like an examination glove. These tests are direct evaluations against performance criteria.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device and testing.
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August 24, 2023
Shandong YINGHONG Medical Products Co., Ltd. % Jason Ji Official Correspondent Intco Medical Industries, Inc 805 Barrington Ave. Ontario. California 91764
Re: K222103
Trade/Device Name: Nitrile Patient Examination Gloves, Powder Free, Pink Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 11, 2022 Received: July 21, 2023
Dear Jason Ji:
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,
Allan Guan -S
For Bifeng Qian, M.D., 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222103
Device Name
Nitrile Patient Examination Gloves, Powder Free, Pink Color
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers 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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Shandong YINGHONG Medical Products Co., Ltd.
No.15 East Road, Hongrun Industry Park, Qingzhou, Shandong, China
510(K) SUMMARY K22103
1. Submitter's Identification:
Shandong YINGHONG Medical Products Co., Ltd No.15 East Road, Hongrun Industry Park, Qingzhou, Shandong, China
Contact Person :
Emily Dong Tel: +86-5366136888
Submission Correspondent
Company: Intco Medical Industries, Inc 805 Barrington Ave Ontario, CA 91764 Primary Contact Name: Jason Ji Tel: 1-909-980-1678 (Ext: 113) Email: jasonji@intcous.com Secondary Contact: John Zhao Tel: 1-909-980-1678 (Ext:112) Email: johnzhao@basicmedical.com
Date summary prepared:
August 10, 2023
Product Trade Name: Nitrile Patient Examination Gloves, Powder Free, Pink Color
3. Device Classification Name:
Non-Powdered Patient Examination Gloves
- Regulation Number: 4. 21 CFR 880.6250
- રે. Device Class: Class I.
- Product Code: 6. LZA.
-
- Predicate Devices: K190942 – Ever Growth (Vietnam) Co., Ltd.
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8. Device Description:
The subject device in this 510(k) Notification is Nitrile Patient Examination Gloves, Powder Free, Pink Color. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I).
These gloves are pink in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL).
Indications for Use: 9.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
| Characteristicsand Parameters | Shandong YINGHONGMedical Products Co.,Ltd.Nitrile PatientExamination Gloves,Powder Free, Pink Color | Ever Growth (Vietnam) Co.,Ltd.Disposable Powder FreeNitrile Examination Glove,Pink Color | ComparisonAnalysis |
|---|---|---|---|
| K-Number | K222103(Subject Device) | K190942(Predicate) | - |
| Product Code | LZA | LZA | Same |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended use | A patient examinationglove is a disposabledevice intended formedical purposes that isworn upon theexaminer's hands orfinger to preventcontamination betweenpatient and examiner. | The Nitrile Powder Freepatient examination glove is anon- sterile disposable deviceintended for medical purposesthat is worn on the examiner'shands or finger to preventcontamination between patientand examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Pink | Pink | Same |
| Single Use | Yes | Yes | Same |
| Sterile vsNon-Sterile | Non-Sterile | Non-Sterile | Same |
| Powdered orPowder Free | Powder Free | Powder Free | Same |
| Complies with ASTMD6319-19Overall Length (mm)For XS, S,Min 220mmFor M, L, XL, XXLMin 230mm | Complies with ASTMD6319-10Overall Length (mm)For XS, S,Min 220mmFor M, L, XLMin 230mm | ||
| DimensionsASTMD6319-19 | Complies withASTM D6319-19X-Small 70±10mmSmall 80±10mmMedium 95±10mmLarge 110±10mmX Large 120±10mmXX Large 130 ±10mm | Complies withASTM D6319-10X-Small 70±10mmSmall 80 ±10mmMedium 95±10mmLarge 110±10mmX Large 120 ±10mmXX Large N/A | 1Different |
| ThicknessPalm - 0.05mm min.Finger - 0.05 mm min.Meets ASTM D6319-19 | ThicknessPalm - 0.05mm min.Finger - 0.05 mm min.Meets ASTM D6319-10 | Same | |
| PhysicalpropertiesASTMD6319-19 | Tensile Strength:Before Aging14 MPa, min.After Aging14 MPa, min.Elongation:Before Aging 500% min.After Aging 400% min. | Tensile Strength:Before Aging14 MPa, min.After Aging14 MPa, min.Elongation:Before Aging 500% min.After Aging 400% min. | Similar |
| Freedomfrom pinholesASTMD6319-19ASTMD5151-19 | In accordance withASTM D6319-19 andASTM D5151- 19,G-1, AQL 2.5 | In accordance withASTM D6319-10 andASTM D5151-06G-1, AQL 2.5 | Similar |
| Residualpower testASTMD6124-06 | Three Lot,Averagepower residue <2mg perglove | Average powder residue< 2mg per glove | Same |
| Skin IrritationTestISO 10993-10 | Passed.Under the conditions ofstudy, not an irritant. | Passed.Under the conditions of study,not an irritant. | Same |
| SkinSensitizationTestISO 10993-10 | Passed.Under the conditions ofstudy, not a sensitizer | Passed.Under the conditions of study,not a sensitizer | Same |
| In VitroCytotoxicity testISO 10993-5 | PassedUnder conditions of thestudy, device extract isnon-cytotoxic | PassedUnder conditions of thestudy, device extract isnon-cytotoxic | Same |
10. Technological Characteristics Comparison Table:
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1 The subject device sizes ranges from XS – XXL, whereas the predicate device size ranges from XS-XL. the predicate device. All sizes for the subject device meet the requirements of ASTM D6319-19.
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11. Discussion of Non-Clinical Tests:
Summary of Non-Clinical Testing
A Biocompatibility
- Biocompatibility Testing was performed according to the following tests for the subject device to evaluate the biocompatibility of Nitrile Patient Examination Gloves, Powder Free, Pink Color
- ISO 10993-10:2010 Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization.
- ISO 10993-5:2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
> Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
· ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.
- 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.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions(length) (width)(thickness)ASTMD6319-19 | The purpose of the test isto evaluate the physicaldimension of the glove | Length220 mm min (XS, S)230 mm min (M, L, XL, XXL) | Pass240 mm min |
| Width (mm)XS: 70±10S: 80±10M: 95±10L: 110±10XL: 120±10XXL: 130±10 | PassXS: average 78.4mmS: average 86.2mmM: average 97.4mmL: average 108.7mmXL: average 115.5mmXXL: average 123.5mm | ||
| Thickness(mm):Palm:Minimum 0.05Finger:Minimum 0.05 | PassPalm - 0.056mm min.Finger - 0.082mm min | ||
| PhysicalpropertiesASTMD6319-19 | The purpose of the test isto evaluate the tensilestrength and ultimateelongation before andafter aging | Before Aging:Tensile Strength: 14 MPa, min.Elongation: 500%, min.After Aging:Tensile Strength: 14 MPa, min.Elongation: 400%, min. | PassBefore Aging:Tensile Strength: 20.6MPa, min.Elongation: 531%, min.After Aging:Tensile Strength: 21.9MPa, min.Elongation: 416%, min. |
| Freedomfrom holesASTMD5151-19 | The purpose of thetest is to detect holes inthe gloves | ||
| ResidualPowderASTMD6124-06 | The purpose of the test isto detect the powderresidue in the glove | <2mg per glove | PassAverage 0.15 mg per glove |
| In VitroCytotoxicityTestISO 10993-5 | To determine the cytotoxicpotential of the glove. | Under the conditions of the study, thedevice is not cytotoxic | PassUnder the conditions of the study, thedevice have no cytotoxic effect |
| SkinSensitizationTestISO 10993-10 | To determine the skinsensitization potential ofthe glove. | Under the conditions of the study, thedevice is not a sensitizer | PassUnder the conditions of the study, thedevice is not a sensitizer. |
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| Skin IrritationTestISO 10993-10 | To determine the potentialof the glove under test toproduce irritation. | Under the conditions of the study, thedevice is not an irritant | PassUnder the conditions of the study, thedevice is not an irritant. |
|---|---|---|---|
| ----------------------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------------------------------- | ------------------------------------------------------------------------------ |
12. Discussion of Clinical Tests:
Not Applicable
13. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that Shandong YINGHONG Medical Products Co., Ltd. Nitrile Patient Examination Gloves, Powder Free, Pink Color is as safe, as effective, and performs as well as or better than the legally marketed device, Disposable Powder Free Nitrile Examination Glove, Pink Color by Ever Growth (Vietnam) Co., Ltd., cleared under K190942.
§ 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.