(90 days)
The disposable nitrile medical 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 available in color blue and white, and it provides five specifications: XS,S, M, L, and XL. The subject device is non-sterile.
The provided text describes the acceptance criteria and the study results for a Disposable Nitrile Examination Glove.
Here's the information extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-23:2021 Tests For Irritation | To determine if device is a skin irritant | The device must be a non-irritant | Pass |
| ISO 10993-10:2021 Tests For Skin Sensitization | To determine if device is a skin sensitizer | The device must be a non-sensitizer | Pass |
| ISO 10993-5:2009 Tests For In Vitro Cytotoxicity | To determine if the device is potential toxicity to L-929 cells. | The device must be a non toxicity. | Cytotoxic (Note: The summary later states this is the same as the reference device and does not affect substantial equivalence due to acute systemic toxicity results.) |
| ISO 10993-11:2017 Tests for Acute systemic toxicity | To determine if the device will cause acute systemic toxicity in vivo | The device must be a Non-acute systemic toxicity | Pass |
| ASTM D6319 (Physical Dimensions) | Physical Dimensions Test | Length(mm): S:≥220; M/L/XL:≥230; Width(mm): XS: 70±10mm; S:80±10mm; M:95±10mm; L: 110±10mm; XL: 120±10mm; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: > 240/Pass (for all sizes) Width (Blue color): XS: 74-76 /Pass; S: 82-86 /Pass; M: 95-97/ Pass; L: 104-106/ Pass; XL:115-117/ Pass Width (White Color): XS: 73-76 /Pass; S: 80-87 /Pass; M: 100-103/ Pass; L: 104-106/ Pass; XL:114-117/ Pass Thickness (Blue color): XS: Finger:0.10-0.12/Pass, Palm: 0.06-0.10/Pass; S: Finger: 0.09-0.12/Pass, Palm:0.07-0.09/Pass; M: Finger: 0.08 -0.12/Pass, Palm: 0.07-0.09/Pass; L: Finger: 0.09-0.12/Pass, Palm: 0.06-0.09/Pass; XL: Finger: 0.11-0.12/Pass, Palm: 0.06-0.09/Pass Thickness (White Color): Details for XS are visible, other sizes indicated but not fully detailed, likely indicating pass. |
| ASTM D6319 (Physical Properties) | Tensile Strength | Before Aging: ≥14MPa, After Aging: ≥14MPa | Before Aging: Blue color: 20-30/Pass; White Color: 16-35/Pass After Aging: Blue color: 20-30/Pass; White Color: 16-35/Pass |
| ASTM D6319 (Physical Properties) | Ultimate Elongation | Before Aging: ≥500%, After Aging: ≥400% | Before Aging: Blue color: 511-565/Pass; White Color: 436-521/Pass After Aging: Blue color: 511-565/Pass; White Color: 436-521/Pass |
| ASTM D6319 / ASTM D5151-19 | Freedom from Holes | G-1, AQL 2.5 | Complies with ASTM D6319-19 and ASTM D5151-19, G-1, AQL 2.5 (Implies Pass) |
| ASTM D6319-19 | Powder Content | < 2 mg per glove | Complies with ASTM D6319-19 (Implies Pass) |
| ASTM D6124-06 (Reapproved 2017) | Residual Powder on Medical Gloves | (Not explicitly stated in table, but standard implies criteria) | (Implied to be compliant as "adequately demonstrate the effectiveness") |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test beyond the implication that sufficient samples were tested to meet the requirements of the listed ASTM and ISO standards. These standards typically define appropriate sampling plans.
- Data Provenance: The text does not specify the country of origin for the data (e.g., where the tests were conducted or the materials sourced from). The study is non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the described tests are laboratory-based physical and biocompatibility evaluations, not assessments requiring expert interpretation of diagnostic images or clinical scenarios.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the described tests are laboratory-based physical and biocompatibility evaluations.
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. This submission is for a disposable nitrile examination glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This submission is for a disposable nitrile examination glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests relies on established scientific and engineering standards and methodologies defined by organizations such as ISO and ASTM. For example, for tensile strength, the ground truth is the specified MPa value; for freedom from holes, it's the AQL (Acceptable Quality Limit). For biocompatibility, it's the biological response observed according to the specific ISO test protocols.
8. The sample size for the training set:
- This information is not applicable. This submission is for a physical medical device (glove), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable. No training set was used.
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January 19, 2023
Yangzhou Saraguard Medical Supplies Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K223250
Trade/Device Name: Disposable Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 20, 2022 Received: December 20, 2022
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.
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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.
Bifeng Qian -S
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) K223250
Device Name Disposable Nitrile Examination Glove
Indications for Use (Describe)
The disposable nitrile medical 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)
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510(k) Summary
K223250
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Yangzhou Saraguard Medical Supplies Co.,Ltd. Name: Standard Workshop No. 1, Phase I, Comprehensive Bonded Zone, No. 9, Address: Yangtze Jiangnan Road, Yangzhou City, Jiangsu Province, China Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: Oct.21,2022
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Nitrile Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS,S, M, L, XL
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Predicate Device#:
| Manufacturer: | Ever Global (Vietnam) Enterprise Corp |
|---|---|
| Device: | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color |
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510(k) number: K171422
Reference Device#:
Manufacturer: GUANG DONG KINGFA SCI. & TECH.CO., LTD. Device: Nitrile examination gloves 510(k) number: K203593
5.0 Indication for Use
The disposable nitrile medical 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 available in color blue and white, and it provides five specifications: XS,S,M,L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
Table1-General Comparison
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| Item | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| Product Code | LZA | LZA | LZA | Same |
| 510(k) Reference | K223250 | K171422 | K203593 | |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | I | Same |
| IntendedUse/Indication for Use | The disposable nitrilemedicalexaminationglove is a non-steriledisposabledeviceintended for medicalpurposes that is worn onthe examiner's hands orfinger to preventcontamination betweenpatient and examiner. | The Nitrile powder freepatient examination Glove,is a non-sterile disposabledevice intended formedical purposes that isworn on the examiner'shands or finger to preventcontamination betweenpatient and examiner. | The nitrile examinationglove is intended to be wornon the hands of examinersto prevent contaminationbetween patient andexaminer. This is a single-use, powder-free, non-sterile device. | Same |
| Powdered or Poweredfree | Powdered free | Powdered free | Powdered free | Same |
| Device materialcomposition | Nitrile | Nitrile | Nitrile | Same |
| Gloves sizes | XS,S,M,L,XL | XS,S,M,L,XL | S,M,L,XL | Same |
| If gloves are singleuse | Yes | Yes | Yes | Same |
| Design Feature | Ambidextrous | Ambidextrous | Ambidextrous | Same |
| Sterile vs Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Color | Blue/White | White/ Blue/ Black/ Pink | Blue | Similar |
| Dimensions - Length | Complies with ASTMD6319-19:XS/S: ≥220 mm;M/L/XL: ≥230 mm. | Complies with ASTMD6319-19: ≥230 mm. | Complies with ASTMD6319-19:S:≥220;M/L/XL: ≥230 | Similar |
| Dimensions - Width | Complies with ASTMD6319-19:XS: 70±10mm;S:80±10mm;M:95±10mm;L: 110±10mm;XL: 120±10mm; | Complies with ASTMD6319-19:XS: 75±5mm;S:85±5mm;M:95±5mm;L: 105±5mm;XL: 115±5mm; | Complies with ASTMD6319-19:S: 80±10mm;M: 95±10mm;L: 110±10mm;XL: 120±10mm | Similar |
| Dimensions -Thickness | Complies with ASTMD6319-19Palm:≥0.05mmFinger: ≥0.05mm | Complies with ASTMD6319-19Palm:≥0.05mmFinger: ≥0.05mm | Complies with ASTMD6319-19Palm:≥0.05mmFinger: ≥0.05mm | Same |
| Physical Properties -Tensile Strength | Complies with ASTMD6319-19:Before Aging: ≥14MPaAfter Aging: ≥500% | Complies with ASTMD6319-19:Before Aging: ≥14MPaAfter Aging: ≥500% | Complies with ASTMD6319-19:Before Aging: ≥14MPaAfter Aging: ≥500% | Same |
| Physical Properties -Elongation | Complies with ASTMD6319-19:Before Aging: ≥14MPaAfter Aging: ≥400% | Complies with ASTMD6319-19:Before Aging: ≥14MPaAfter Aging: ≥400% | Complies with ASTMD6319-19:Before Aging: ≥14MPaAfter Aging: ≥400% | Same |
| Freedom from Holes | Complies with ASTMD6319-19and ASTM D5151-19 | Complies with ASTMD6319-19and ASTM D5151-19 | Complies with ASTMD6319-19and ASTM D5151-19 | Same |
| G-1, AQL 2.5 | G-1, AQL 2.5 | G-1, AQL 2.5 | ||
| Powder Content | Complies with ASTM D6319-19, < 2 mg per glove | Complies with ASTM D6319-19. | Complies with ASTM D6319-19. | Same |
| Biocompatibility- Irritation Test | ISO 10993-23;Under the conditions of the study, not an irritant | Comply with Comply with ISO10993-10 | ISO 10993-23;Under the conditions of the study, not an irritant | Same |
| Biocompatibility- Sensitization Test | ISO 10993-10;Under the conditions of the study, not a sensitizer | Comply with Comply with ISO10993-10 | ISO 10993-10;Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility- Acute SystemicToxicity | 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 10993-11;Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | Different |
| Biocompatibility-Cytotoxicity | ISO 10993-5Under conditions of the study, device extract is cytotoxic | Not Publicly Available | ISO 10993-5Under conditions of the study, device extract is cytotoxic | Different |
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Analysis:
The color(blue/white) of the subject device is different with those (white/ blue/ black/ pink) of the predicate device, biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards.
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The physical dimensions are little different with that of the predicate, but they all meet the requirements of ASTM D6319. Therefore, the differences will not raise any safety and effectiveness issues.
For the Biocompatibility- Cytotoxicity and Acute Systemic Toxicity, at the neat extraction, the current device is considered cytotoxic, but the acute systemic toxicity results demonstrate the device will not cause a systemic effect, this situation is same with the reference device. So there is no effect on the substantial equivalence to the predicate device.
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8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Nitrile Powder Free Examination Gloves, was conducted in accordance with the following standards:
ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: T Part 10: Tests for skin sensitization.
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation;
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-23:2021 TestsFor Irritation | To determine if device is askin irritant | The device must be anon-irritant | Pass |
| ISO 10993-10:2021 TestsFor Skin Sensitization | To determine if device is askin sensitizer | The device must be anon- sensitizer | Pass |
| ISO 10993-5:2009Tests For In VitroCytotoxicity | To determine if the deviceis potential toxicity to L-929cells. | The device must be anon toxicity. | Cytotoxic |
| ISO 10993-11:2017 Testsfor Acute systemic toxicity | To determine if the devicewill cause acute systemictoxicity in vivo | The device must be aNon- acute systemictoxicity | Pass |
| TestMethod | Purpose | Acceptance Criteria | Results |
| ASTMD6319 | PhysicalDimensionsTest | Length(mm):S:≥220;M/L/XL:≥230;Width(mm):XS: 70±10mm;S:80±10mm;M:95±10mm;L: 110±10mm;XL: 120±10mm | Length:> 240/Pass;Width:Blue color:XS: 74-76 /PassS: 82-86 /PassM: 95-97/ PassL: 104-106/ PassXL:115-117/ PassWhite Color:XS: 73-76 /PassS: 80-87 /PassM: 100-103/ PassL: 104-106/ PassXL:114-117/ Pass |
| Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | Blue color:XS:Finger:0.10-0.12/PassPalm: 0.06-0.10/PassS:Finger: 0.09-0.12/PassPalm:0.07-0.09/PassM:Finger: 0.08 -0.12/PassPalm: 0.07-0.09/PassL:Finger: 0.09-0.12/PassPalm: 0.06-0.09/PassXL:Finger: 0.11-0.12/PassPalm: 0.06-0.09/PassWhite Color:XS: |
Table 2 Biocompatibility Testing
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
In summary, 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 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 -
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Medical Application.
Table 3 Non-Clinical Testing
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| AfterAging | TensileStrength | $\geq$ 14MPa | Blue color:20-30/Pass.White Color:16-35/Pass. | |
|---|---|---|---|---|
| UltimateElongation | $\geq$ 400% | Blue color:511-565/PassWhite Color:436-521/Pass. |
9.0 Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device under 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.